item: #1 of 48 id: cord-001513-p7v5p036 author: Ekins, Sean title: A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus date: 2014-12-12 words: 4760 flesch: 53 summary: Because the original complete sets of FDA approved compounds screened are not publically accessible it is difficult to compare hit rates versus all compounds tested to date. This pharmacophore (with an added van der Waals surface to limit the number of hits retrieved) was then used to screen and score other FDA drugs from score particularly well in terms of docking to VP35. keywords: compounds; docking; ebov; features; ligand; pharmacophore; protein cache: cord-001513-p7v5p036.txt plain text: cord-001513-p7v5p036.txt item: #2 of 48 id: cord-002626-jzwwses4 author: Kaul, Karen L. title: The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care date: 2017-07-16 words: 14833 flesch: 34 summary: [79] [80] [81] Instrumentation from Thermo Fisher (Thermo Fisher Life-Technologies, Carlsbad, CA, USA) and Illumina (Illumina, San Diego, CA, USA), the Personal Genome Machine (PGM), and MiSeq, have made NGS suitable for routine clinical laboratory testing. Laboratory testing for FX includes sizing the number of repeats as well as methylation analysis and has been available for clinical diagnostic and carrier status testing for over 20 years. keywords: assays; braf; cancer; care; clinical; data; diagnosis; disease; fda; gene; guidelines; laboratories; laboratory; ldps; methods; mutations; new; patients; performance; quality; results; risk; sequencing; testing; tests; therapy; treatment; use; virus cache: cord-002626-jzwwses4.txt plain text: cord-002626-jzwwses4.txt item: #3 of 48 id: cord-003118-58ta20fg author: Van Norman, Gail A. title: Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies date: 2018-06-25 words: 2205 flesch: 28 summary: While these pathways provide potential access for individual patients to investigational drugs, different EA pathways permit entire groups of certain patients to access investigational drugs prior to FDA approval. This review focuses on special categories of EA INDs intended for multiple patients—the intermediate-group IND and the widespread-treatment IND—as well as emergency authorization for use of investigational drugs and biological products (e.g., vaccines) in public health emergencies. keywords: access; drug; fda; patients; treatment; use cache: cord-003118-58ta20fg.txt plain text: cord-003118-58ta20fg.txt item: #4 of 48 id: cord-010119-t1x9gknd author: None title: Abstract Presentations from the AABB Annual Meeting San Diego, CA ctober 7‐10, 2017 date: 2017-09-04 words: 230433 flesch: 50 summary: Probability of occurrence of cannabis metabolites in blood donor samples is likely to be highly variable across donor centers and is largely dependent on blood donor demographics. OBRR, CBER, FDA Background/Case Studies: Extended molecular typing of a large number of blood donors can increase the likelihood of identifying donor red blood cells (RBCs) that match those of the recipient. keywords: abo; abo blood; acute; addition; alleles; alloimmunization; analysis; anemia; anti; antibodies; antibody; antigen; apheresis; approach; assay; average; background; bacterial; blood; blood bank; blood cells; blood center; blood collection; blood components; blood count; blood donation; blood donors; blood group; blood loss; blood management; blood order; blood ordering; blood products; blood safety; blood samples; blood screening; blood services; blood specimens; blood supplier; blood supply; blood system; blood testing; blood transfusion; blood type; blood units; blood volume; care; case studies; case study; cases; cd36; cell transfusion; center background; centers; change; clinical; collections; concentration; conclusion; control; cord blood; cost; count; cross; culture; current; data; days; decreased; detection; difference; disease; dna; donations; donor samples; dose; dtt; effect; emergency blood; evaluation; events; evidence; expression; factors; fda; female; ffp; finding; flow; following; frequency; fresh; gel; gene; genotyping; given; groups; hbv; hcv; health; hemoglobin; hemolysis; high; history; hiv; hla; hospital; hospital blood; hospital transfusion; hours; human; identification; igg; immucor; impact; implementation; improvement; incidence; increase; infection; information; initial; institution; inventory; iron; laboratory; levels; low; manual; mean; median; medical; method; mice; minutes; model; molecular; months; mtp; need; negative; new; non; normal; number; order; partial; pathogen; patients; pcr; performance; period; phase; phenotype; plasma; plasma samples; plasma transfusion; plasma units; platelet; platelet blood; platelet transfusion; platelet units; plt; plts; population; positive; post; post transfusion; potential; practice; pre; presence; present; prevalence; procedure; process; processing; program; protocol; quality; r blood; range; rate; rbc; rbc blood; rbc transfusion; rbc units; rbcs; reactive; reactivity; reagent; recipients; recovery; red; reduced; reduction; reference; report; response; results; review; rhd; risk; routine; screening; second; sensitivity; sequencing; serum; set; small; solution; specific; specificity; staff; standard; storage; study design; study period; survey; systems; table; technology; test results; testing; tests; therapy; time; titer; total; tpe; training; transfused; transfusion medicine; transfusion practice; transfusion protocol; transfusion reactions; transfusion results; transfusion service; transfusions; trauma; treatment; tube; typing; units; university; use; values; virus; wastage; wbc; weak; weeks; women; year; zika; zikv cache: cord-010119-t1x9gknd.txt plain text: cord-010119-t1x9gknd.txt item: #5 of 48 id: cord-014687-0am4l5ms author: None title: SPR 2012 date: 2012-03-29 words: 98702 flesch: 39 summary: Image Gently has succeeded not only in raising awareness of the great diagnostic benefits we can offer to pediatric patients but also directs us to acknowledge the downside of overzealous diagnostic efforts where excessive radiation becomes a risk. Methods & Materials: Pediatric patients who had high temporal resolution cine Steady State Free Precession sequence (50 frames acquired across a single cardiac cycle) performed as part of a MRI/MRA of the heart from 2005-2011 were included. keywords: abnormalities; acute; age; airway; anatomy; anomalies; appearance; approach; assessment; average; blood; body; bone; bowel; brain; brain mri; cardiac; care; case report; cases; center; chest; children; complications; conclusions; conditions; contrast; correlation; ct imaging; data; days; development; diagnosis; diffusion; disease; disorders; dose; evaluation; exhibit; fat; fetal; flow; follow; following; fractures; group; head; heart; high; hospital; images; imaging; imaging features; imaging findings; imaging modalities; imaging studies; infants; information; injury; institution; left; lesions; level; literature; liver; low; lung; malformations; management; mass; masses; materials; mean; medical; methods; months; mr imaging; mri; mri findings; neck; neonatal; new; noise; non; obstruction; pathology; patients; pediatric; population; post; posterior; potential; prenatal; present; presentation; protocol; pulmonary; purpose; quality; radiation; radiographs; radiologists; radiology; range; renal; resolution; resonance imaging; results; review; right; role; scan; size; spectrum; spinal; spine; spr; studies; study; surgery; syndrome; system; technique; time; tissue; treatment; tumor; ultrasound; university; use; value; vascular; venous; years cache: cord-014687-0am4l5ms.txt plain text: cord-014687-0am4l5ms.txt item: #6 of 48 id: cord-016293-pyb00pt5 author: Newell-McGloughlin, Martina title: The flowering of the age of Biotechnology 1990–2000 date: 2006 words: 22413 flesch: 45 summary: These DNA chips have broad commercial applications and are now used in many areas of basic and clinical research including the detection of drug resistance mutations in infectious organisms, direct DNA sequence comparison of large segments of the human genome, the monitoring of multiple human genes for disease associated mutations, the quantitative and parallel measurement of mRNA expression for thousands of human genes, and the physical and genetic mapping of genomes. Of course for such a radical approach certain basal level criteria needed to be established for selecting disease candidates for human gene therapy. keywords: animal; biology; biotechnology; cancer; cells; company; data; development; disease; dna; drug; expression; food; gene; gene therapy; genome; human; influenza; information; level; molecular; nih; number; plant; production; products; project; protein; research; rna; scientists; sequence; sequencing; stem cells; studies; system; techniques; technology; therapy; time; transfer; transgenic; university; use; virus; year cache: cord-016293-pyb00pt5.txt plain text: cord-016293-pyb00pt5.txt item: #7 of 48 id: cord-016640-pvlg3nkp author: Baron, Ellen Jo title: Technical and Clinical Niches for Point of Care Molecular Devices date: 2012-04-05 words: 2869 flesch: 37 summary: No molecular test has yet achieved CLIA waived status (although some are being developed for FDA submission), so POC molecular tests are still physician's of fi ce lab or satellite lab tests rather than true bedside methods. Several pathogens can be detected in patient samples using molecular tests within 4 h. However, there are formidable obstacles to moving molecular diagnostics into the POC setting. keywords: assay; detection; fda; methods; patients; pcr; poc; test cache: cord-016640-pvlg3nkp.txt plain text: cord-016640-pvlg3nkp.txt item: #8 of 48 id: cord-017208-7oew461e author: Aurigemma, Rosemarie title: Regulatory Aspects in the Development of Gene Therapies date: 2005 words: 18332 flesch: 33 summary: S7A safety pharmacology studies for human pharmaceuticals Code of Federal Regulations, Title 21, Food and Drugs, Part 610.10, Subpart B, General biological products standards; general provisions; potency Code of Federal Regulations, Title 21, Food and Drugs, Part 610.12, Subpart B, General biological products standards Code of Federal Regulations, Title 21, Food and Drugs, Part 610.13, Subpart B, General biological products standards Code of Federal Regulations, Title 21, Food and Drugs, Part 610.14, Subpart B, General biological products standards Code of Federal Regulations, Title 21, Food and Drugs, Part 58, Good laboratory practice for nonclinical laboratory studies Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals Code of Federal Regulations, Title 21, Food and Drugs, Part 312, Investigational new drug application INDs) for phase I studies of drugs, including well-characterized, therapeutic, biotechnology-derived products FDA guidance for industry: IND's for phases 2 and 3 studies of drugs, including specified therapeutic biotechnology-derived products, chemistry, manufacturing and controls content and format FDA guidance for industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product FDA guidance for industry for the submission of chemistry, manufacturing, and controls information for a therapeutic recombinant DNA-derived product or a monoclonal antibody product for in vivo use FDA guidance for industry: formal meetings with sponsors and applicants for PDUFA products FDA points to consider in the manufacturing and testing of monoclonal antibody products for human use FDA letter to manufacturers of biological products: recommendations regarding bovine spongiform encephalopathy (BSE) FDA Biological Response Modifiers Advisory Committee: current policy on sequence characterization of gene transfer products FDA Biological Response Modifiers Advisory Committee: adenovirus titer measurements and RCA levels FDA guidance for industry: supplemental guidance on testing for replication competent retrovirus in retroviral vector based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors FDA points to consider in the characterization of cell lines used to produce biologicals FDA gene therapy patient tracking system final document FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products Third national NIH gene transfer safety symposium: safety considerations in the use of AAV vectors in gene transfer clinical trials Basic principles of gene therapy: basic principles and safety considerations Preclinical animal models in gene therapy research A new animal model for human respiratory tract disease due to adenovirus Use of Aotus monkey to assess neurovirulence of replication-selective herpes vectors Herpes simplex type 1 infects and establishes latency in the brain and trigeminal ganglia during primary infection of the lip in cotton rats and mice Tropism of human adenovirus type 5-based vectors in swine and their ability to protect against transmissible gastroenteritis coronavirus Porcine toxicology studies of SCH 58500, an adenoviral vector for the p53 gene Pathogenesis of adenovirus type 5 pneumonia in cotton rats (Sigmodon hispidus) As a result, it was only natural that these animals be used to evaluate the safety of gene therapy vectors produced from HSV-1. keywords: adenovirus; administration; agent; animal; assays; cell; cgmp; development; dose; evaluation; fda; gene; gene therapy; human; preclinical; product; production; recombinant; replication; response; safety; studies; therapy; toxicity; transfer; use; vector; virus cache: cord-017208-7oew461e.txt plain text: cord-017208-7oew461e.txt item: #9 of 48 id: cord-017413-ymo9h7wb author: Nurudeen, Sahadat Kemi title: Selecting and Screening Donors date: 2012-10-19 words: 7165 flesch: 37 summary: The indications for donor oocyte in vitro fertilization (IVF) have now expanded to include not only women with hypergonadotropic hypogonadism but also those with advanced reproductive age, diminished ovarian reserve, significant genetic disease risk, poor oocyte or embryo quality, or multiple failures in prior attempts to conceive using conventional assisted reproductive technology (ART). The indications for donor oocyte in vitro fertilization (IVF) have now expanded to include not only women with hypergonadotropic hypogonadism but also those with advanced reproductive age, diminished ovarian reserve, signi fi cant genetic disease risk, poor oocyte or embryo quality, or multiple failures in prior attempts to conceive using conventional assisted reproductive technology (ART). keywords: disease; donation; donors; egg; history; infection; offspring; oocyte; ovarian; potential; risk; screening; testing; women cache: cord-017413-ymo9h7wb.txt plain text: cord-017413-ymo9h7wb.txt item: #10 of 48 id: cord-018566-dd5gw66t author: Armbruster, Walter J. title: The Political Economy of US Antibiotic Use in Animal Feed date: 2018-05-30 words: 11426 flesch: 31 summary: To the extent they can be developed and used separately, the potential for animal antibiotic use leading to antimicrobial resistance for important human antibiotics will be mitigated. Despite the scientific and economic evidence, many comments to the proposed final regulation reflected ongoing resistance to the elimination of food animal production use of medically important antibiotics. keywords: agriculture; animal; antibiotics; antimicrobials; bacteria; costs; drug; fda; feed; food; health; human; industry; new; production; products; public; resistance; use cache: cord-018566-dd5gw66t.txt plain text: cord-018566-dd5gw66t.txt item: #11 of 48 id: cord-018770-uy76mc2j author: Connelly-Smith, Laura S. title: Donor Evaluation for Hematopoietic Stem and Progenitor Cell Collection date: 2019-11-28 words: 9147 flesch: 33 summary: Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program Older age but not donor health impairs allogeneic granulocyte colony-stimulating factor (G-CSF) peripheral blood stem cell mobilization Efficacy and safety of peripheral blood stem cell mobilization and collection: a single-center experience in 190 allogeneic donors Haematopoietic stem cell donor registries: World Marrow Donor Association recommendations for evaluation of donor health Retrospective analysis of 37,287 observation years after peripheral blood stem cell donation Children as hematopoietic cell donors in research: when is it approvable? All donors must be medically evaluated to detect conditions that might significantly increase donor risk to unacceptable levels and to ensure their safety to donate. keywords: allogeneic; blood; cell; collection; diseases; donation; donor; et al; history; hpc; human; marrow; products; risk; screening; stem; transplantation cache: cord-018770-uy76mc2j.txt plain text: cord-018770-uy76mc2j.txt item: #12 of 48 id: cord-022039-y0l943xg author: Gruber, Marion F. title: Regulation and Testing of Vaccines date: 2017-07-17 words: 14886 flesch: 29 summary: Characterization of cell substrates should address certain general issues that might affect the safety and purity of vaccine products. The Vaccine Safety Datalink uses electronic health data from participating sites and conducts vaccine safety studies based on questions or concerns raised from the medical literature and VAERS reports. keywords: act; cber; data; development; disease; drug; efficacy; fda; guidance; health; human; industry; information; licensure; process; product; review; safety; studies; trials; use; vaccines cache: cord-022039-y0l943xg.txt plain text: cord-022039-y0l943xg.txt item: #13 of 48 id: cord-022053-idft1p6d author: Pecora, Nicole title: New Technologies for the Diagnosis of Infection date: 2017-07-21 words: 11502 flesch: 32 summary: RVP fast multiplex assays for detection of respiratory viruses Phylogenetic structure of the prokaryotic domain: the primary kingdoms Then and now: use of 16S rDNA gene sequencing for bacterial identification and discovery of novel bacteria in clinical microbiology laboratories Report of the ad hoc committee for the re-evaluation of the species definition in bacteriology Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline Broad-range 16S rRNA gene polymerase chain reaction for diagnosis of culturenegative bacterial infections Utility of 16S rDNA sequencing for identification of rare pathogenic bacteria Identification of bacteria in formalin-fixed, paraffin-embedded heart valve tissue via 16S rRNA gene nucleotide sequencing 16S rRNA sequencing in routine bacterial identification: a 30-month experiment Improved diagnosis of mycobacterial infections in formalin-fixed and paraffin-embedded sections with nested polymerase chain reaction Rapid real-time PCR for detection of Mycobacterium tuberculosis complex DNA in formalin-fixed paraffin embedded tissues: 16% of histological 'sarcoid' may contain such DNA Broad-range PCR and sequencing in routine diagnosis of infective endocarditis Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock Emerging technologies for rapid identification of bloodstream pathogens ID learning unit-diagnostics update: current laboratory methods for rapid pathogen identification in patients with bloodstream infections Nonculture techniques for the detection of bacteremia and fungemia an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection Multicenter evaluation of the BioFire FilmArray gastrointestinal panel for etiologic diagnosis of infectious gastroenteritis Comparative evaluation of two commercial multiplex panels for detection of gastrointestinal pathogens by use of clinical stool specimens Spectrum of enteropathogens detected by the FilmArray GI panel in a multicentre study of community-acquired gastroenteritis Multi-center clinical evaluation of a multiplex meningitis/encephalitis PCR panel for simultaneous detection of bacteria, yeasts and viruses in cerebrospinal fluid specimens General Meeting Enhancing pathogen identification in patients with meningitis and a negative Gram stain using the BioFire FilmArray((R)) Species identification of clinical isolates of Bacteroides by matrixassisted laser-desorption/ionization time-of-flight mass spectrometry Performance of MALDI-TOF MS platforms for fungal identification MALDI-TOF mass spectrometry proteomic phenotyping of clinically relevant fungi Improved clinical laboratory identification of human pathogenic yeasts by matrix-assisted laser desorption ionization time-offlight mass spectrometry Comparison of the accuracy of two conventional phenotypic methods and two MALDI-TOF MS systems with that of DNA sequencing analysis for correctly identifying clinically encountered yeasts Comparative evaluation of the Bruker Biotyper and Vitek MS matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry systems for identification of yeasts of medical importance Interlaboratory comparison of sample preparation methods, database expansions, and cutoff values for identification of yeasts by matrix-assisted laser desorption ionization-time of flight mass spectrometry using a yeast test panel Clinical performance evaluation of the Sofia RSV FIA rapid antigen test for diagnosis of respiratory syncytial virus infection Serological markers in early stages of human immunodeficiency virus infection in haemophiliacs Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology Matrix-assisted laser desorption ionization-time of flight mass spectrometry in clinical microbiology MS for the diagnosis of infectious diseases A side by side comparison of Bruker Biotyper and VITEK MS: utility of screening methods and matrix-assisted laser desorption ionizationtime of flight mass spectrometry Direct identification of urinary tract pathogens from urine samples using the Vitek MS system based on matrix-assisted laser desorption ionization-time of flight mass spectrometry Mass spectrometry: pneumococcal meningitis verified and Brucella species identified in less than half an hour Direct application of MALDI-TOF mass spectrometry to cerebrospinal fluid for rapid pathogen identification in a patient with bacterial meningitis Sample preparation for mass spectrometry analysis of formalin-fixed paraffin-embedded tissue: proteomic analysis of formalin-fixed tissue Urinary pellet sample preparation for shotgun proteomic analysis of microbial infection and host-pathogen interactions PNA for rapid microbiology Peptide nucleic acid fluorescence in situ hybridization for rapid detection of Klebsiella pneumoniae from positive blood cultures Direct identification of major blood culture pathogens, including Pseudomonas aeruginosa and Escherichia coli, by a panel of fluorescence in situ hybridization assays using peptide nucleic acid probes Rapid identification of Staphylococcus aureus directly from blood cultures by fluorescence in situ hybridization with peptide nucleic acid probes Rapid detection of Enterococcus spp. keywords: analysis; assays; bacterial; biotyper; detection; evaluation; identification; ionization; isolates; laser; maldi; mass; organisms; panel; pathogens; pcr; performance; rapid; sequencing; species; spectrometry; system; time; vitek cache: cord-022053-idft1p6d.txt plain text: cord-022053-idft1p6d.txt item: #14 of 48 id: cord-024833-e6vcf4un author: None title: Forum date: 2019-12-19 words: 8121 flesch: 44 summary: A new requirement of the Cures Act was for the FDA to make its best practices for drug safety surveillance publicly available on the web. The FDA has now announced the availability of a draft document entitled Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff, which outlines the agency's approach to timely postmarketing analyses of drugs and biologics, and includes a high-level overview of tools, methods, and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of our overarching effort and commitment in this area, says Woodcock. keywords: age; authors; cases; data; drug; events; fda; health; healthcare; new; patients; products; reporting; reports; risk; safety; signals; study; use; vaccine; years cache: cord-024833-e6vcf4un.txt plain text: cord-024833-e6vcf4un.txt item: #15 of 48 id: cord-026653-094bk0t0 author: Gülsen, Askin title: Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events* date: 2020-06-24 words: 14021 flesch: 44 summary: ADA were detected in 2-8 % of treated patients, and two subjects developed serum sickness or serum sickness-like reactions. In the last published FDA label, IRs and cytokine release syndrome were reported in 92 % of treated patients, but epinephrine or atropine was administered in 0.6 % of these patients [54] . keywords: anaphylaxis; assessment; cancer; drug; fda; hsrs; hypersensitivity; infusion; irs; isrs; labels; pain; patients; rash; reactions; report; study; symptoms; treatment; urticaria cache: cord-026653-094bk0t0.txt plain text: cord-026653-094bk0t0.txt item: #16 of 48 id: cord-033420-pjtyv0pv author: Kalokairinou, Louiza title: The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues date: 2020-09-23 words: 6323 flesch: 43 summary: Although the regulatory environment for COVID-19 tests is not identical to that for other types of DTC health tests (such as currently marketed genetic or hormone tests), 4 many of the concerns raised by DTC COVID-19 tests parallel those wrought by other types of DTC health tests. We conclude with recommendations for regulators, companies, and other relevant stakeholders that can help ensure high-quality, accurate, and equitably distributed COVID-19 tests, and inform the ethical provision of DTC health tests during public health crises. keywords: companies; concerns; consumer; covid-19; dtc; fda; health; healthcare; testing; tests cache: cord-033420-pjtyv0pv.txt plain text: cord-033420-pjtyv0pv.txt item: #17 of 48 id: cord-253840-xudra8tp author: Gillette, Michael title: Reflections of the Angiotensin Receptor Blocker Recall by the FDA and Repercussions on Healthcare date: 2020-04-21 words: 3319 flesch: 36 summary: Moreover, if cancer risk is indeed associated with AT 2 activation indirectly through AT 1 antagonism, then the cancer risk should be higher with ARBs such as valsartan, olmesartan, azilsartan, and candesartan due to their much higher affinity for the AT 1 receptor [27] [28] [29] . Although other ARBs were not affected by the recall such as azilsartan, candesartan, eprosartan, olmesartan, and telmisartan, it is possible that other generic ARBs could be affected. keywords: angiotensin; arbs; cancer; fda; heart; patients; recall; receptor; valsartan cache: cord-253840-xudra8tp.txt plain text: cord-253840-xudra8tp.txt item: #18 of 48 id: cord-256852-lrz17bdx author: Nayyar, Gaurvika M. L. title: Responding to the Pandemic of Falsified Medicines date: 2015-06-03 words: 4209 flesch: 31 summary: Few functional national regulatory authorities exist in low-income nations that lack trained staff and suitably equipped laboratories to test drug quality centrally or in peripheral pharmacies or markets. The focus of all actions tied to drug quality must be on public and individual health, and strengthening national capacities to improve the health of their citizens. keywords: convention; counterfeit; countries; drugs; health; international; medicines; organization; pharmaceutical; products; quality cache: cord-256852-lrz17bdx.txt plain text: cord-256852-lrz17bdx.txt item: #19 of 48 id: cord-268283-eja8fkwv author: Iftikhar, Hafsa title: Identification of potential inhibitors of three key enzymes of SARS-CoV2 using computational approach date: 2020-06-09 words: 4828 flesch: 40 summary: In this regard, several recent studies have been conducted using computational methods to screen libraries of approved drugs or drug-like molecules to identify potential inhibitors of different viral proteins, particularly, RdRp and 3CL-protease [13] Moreover, several other studies have also been reported contributing to the efforts in identifying approved drugs for repurposing or drug candidates or leads to develop drugs against SARS-CoV-2. keywords: 3cl; binding; cov-2; docking; drug; helicase; potential; protease; proteins; sars; structure cache: cord-268283-eja8fkwv.txt plain text: cord-268283-eja8fkwv.txt item: #20 of 48 id: cord-269194-b1wlr3t7 author: Engstrom-Melnyk, Julia title: Chapter 5 Clinical Applications of Quantitative Real-Time PCR in Virology date: 2015-12-31 words: 12555 flesch: 22 summary: Determining a patient's HIV viral load is indicated prior to entry into care, at the initiation of ART, at 2-8 weeks after ART initiation, and then typically every 3-4 months while on treatment: (1) to establish a baseline level of HIV viral load; (2) to establish viral response to the therapy to assess the virologic efficacy of ART; and (3) to monitor for abnormalities that may be associated with antiretroviral drugs (DHHS HIV, 2014) . (A) HIV viral loads will fluctuate as patients are on treatment, and, in most instances, will remain 'undetectable' (at or below dotted line); viral 'blips' are not uncommon and will result in transient 'detectable' and even quantifiable results (above the dashed line). keywords: assays; chronic; clinical; cmv; disease; et al; fda; hcv; hiv; infection; laboratory; load; molecular; patients; pcr; results; rna; testing; tests; therapy; time; time pcr; transplant; treatment; virus cache: cord-269194-b1wlr3t7.txt plain text: cord-269194-b1wlr3t7.txt item: #21 of 48 id: cord-269975-1ebmq7t8 author: Duplantier, Allen J. title: Combating biothreat pathogens: ongoing efforts for countermeasure development and unique challenges date: 2020-05-27 words: 12977 flesch: 23 summary: infection Protection against filovirus diseases by a novel broad-spectrum nucleoside analogue BCX4430 BioCryst Pharmaceuticals BioCryst announces study results for BCX4430 in a non-human primate model of Ebola Virus infection BioCryst Pharmaceuticals BioCryst announces positive study results for BCX4430 delayed treatment of Ebola virus infection in a non-human primate model Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model Intracellular conversion and in vivo dose response of favipiravir (T-705) in rodents infected with Ebola virus Synthesis of [(18)F] favipiravir and biodistribution in C3H/HeN mice as assessed by positron emission tomography Efficacy of favipiravir (T-705) in nonhuman primates infected with Ebola virus or Marburg virus Post-exposure efficacy of oral T-705 (Favipiravir) against inhalational Ebola virus infection in a mouse model Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys FDA-approved selective estrogen receptor modulators inhibit Ebola virus infection Singledose pharmacokinetic study of clomiphene citrate isomers in anovular patients with polycystic ovary disease A screen of approved drugs and molecular probes identifies therapeutics with anti-Ebola virus activity Categorization and prioritization of drugs for consideration for testing or use in patients infected with Ebola Addressing therapeutic options for Ebola virus infection in current and future outbreaks A rapid screening assay identifies monotherapy with interferon-ss and combination therapies with nucleoside analogs as effective inhibitors of Ebola virus Evaluation of immune globulin and recombinant interferon-alpha2b for treatment of experimental Ebola virus infections Interferon-beta therapy prolongs survival in rhesus macaque models of Ebola and Marburg hemorrhagic fever Postexposure protection of non-human primates against a lethal Ebola virus challenge with RNA interference: a proof-ofconcept study Lipid nanoparticle siRNA treatment of Ebola-virus-Makona-infected nonhuman primates Discovery and early development of AVI-7537 and AVI-7288 for the treatment of Ebola virus and Marburg virus infections Advanced antisense therapies for postexposure protection against lethal filovirus infections A single phosphorodiamidate morpholino oligomer targeting VP24 protects rhesus monkeys against lethal Ebola virus infection A potent Lassa virus antiviral targets an arenavirus virulence determinant Favipiravir (T-705), a novel viral RNA polymerase inhibitor Lassa virus infection of rhesus monkeys: pathogenesis and treatment with ribavirin Usefulness of monitoring ribavirin plasma concentrations to improve treatment response in patients with chronic hepatitis C Stampidine prevents mortality in an experimental mouse model of viral hemorrhagic fever caused by Lassa virus Zidampidine, an aryl phosphate derivative of AZT: in vivo pharmacokinetics, metabolism, toxicity, and anti-viral efficacy against hemorrhagic fever caused by Lassa virus Use of favipiravir to treat Lassa virus infection in macaques GuthrieW.I.P. Organization, N4-hydroxycytidine and derivatives and anti-viral uses related thereto Efficacy of a ML336 derivative against Venezuelan and eastern equine encephalitis viruses Development of (E)-2-((1,4-dimethylpiperazin-2-ylidene)amino)-5-nitro-N-phenylbenzamide, ML336: Monoclonal and cocktail antibody therapies approved by the Food and Drug Administration for countering anthrax and under development for treatment of Ebola virus infection are discussed. keywords: agents; animal; antibodies; antibody; biothreat; burkholderia; cell; combination; development; disease; drug; ebola; efficacy; fever; host; human; infection; inhibitors; model; pathogens; protein; pseudomallei; replication; resistance; screening; studies; target; therapy; treatment; virus; viruses cache: cord-269975-1ebmq7t8.txt plain text: cord-269975-1ebmq7t8.txt item: #22 of 48 id: cord-273099-zkk5d6gd author: Muzumdar, Jagannath M. title: Vaccine supply, demand, and policy: A primer date: 2016-01-01 words: 7504 flesch: 42 summary: Thus, the dearth of suppliers appears to have affected the stability of vaccine supply. Specifically, we sought to (1) highlight issues faced by vaccine manufacturers that make the vaccine industry a unique segment of the prescription drug industry, (2) provide an overview of the vaccine market with regards to vaccine supply and demand, and (3) provide an overview and critical evaluation of policy options proposed and implemented by various parties to address vaccine supply and demand problems. keywords: act; children; costs; demand; development; fda; health; immunization; market; policy; products; safety; states; supply; united; vaccination; vaccine cache: cord-273099-zkk5d6gd.txt plain text: cord-273099-zkk5d6gd.txt item: #23 of 48 id: cord-274061-ynqxgyw6 author: Epstein, Jay S. title: Blood system changes since recognition of transfusion‐associated AIDS date: 2013-10-17 words: 6257 flesch: 34 summary: Improving Blood Safety and Supply in the U.S The efficiency of HIV p24 antigen screening of US blood donors: projections versus reality Risk of human immunodeficiency virus infection from blood donors who later developed the acquired immunodeficiency syndrome Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening Guidelines for counseling persons with human T-lymphotropic virus Type I (HTLV-I) and Type II (HTLV-II) Jaundice occurring one to four months after transfusion of blood or plasma: report of seven cases A serologic follow-up of the 1942 epidemic of post-vaccination hepatitis in the United States Army A new antigen in leukemia sera Australia antigen and acute viral hepatitis Immunologic distinction between infectious and serum hepatitis Virus-like particles in serum of patients with Australia-antigen-associated hepatitis Infectious hepatitis: evidence for two distinctive clinical, epidemiological, and immunological types of infection Posttransfusion hepatitis after open-heart operations Serum hepatitis from transfusions of blood Posttransfusion hepatitis after exclusion of the commercial and hepatitis B antigen positive donor Hepatitis A: detection by immune electron microscopy of a virus-like antigen associated with acute illness Transfusion-associated hepatitis not due to viral hepatitis type A or B Posttransfusion non-A, non-B hepatitis: physiochemical properties of two distinct agents Inactivation of hepatitis B virus and non-A, non-B virus by chloroform Determining the size of non-A, non-B hepatitis virus by filtration The chronic sequelae of non-A, non-B hepatitis Serum alanine aminotransferase of donors in relation to the risk of non-A, non-B hepatitis in recipients: the transfusion-transmitted virus study The relationship of donor transaminase (ALT) to recipient hepatitis: impact on blood transfusion services Hepatitis C virus and eliminating post-transfusion hepatitis Hepatitis B virus antibody in blood donors and the occurrence of non-A, non-B hepatitis in transfusion recipients: an analysis of the Transfusion-Transmitted Virus Study Antibody to hepatitis B core antigen as a paradoxical marker for non-A, non-B hepatitis agents in donated blood Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome An assay for circulating antibodies to a major etiologic virus of non-A, non-B hepatitis Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis and update on West Nile virus infections in recipients of blood transfusions West Nile Virus Transmission Investigation Team. Transmission of West Nile virus through blood transfusion in the United States in 2002 As West Nile virus season heats up, blood safety testing lags behind West Nile virus among blood donors in the United States Screening the blood supply for West Nile virus RNA by nucleic acid amplification testing Triggers for switching from minipool testing by nucleic acid technology to individual-donation nucleic acid testing for West Nile virus: analysis of 2003 data to inform 2004 decision making Transmissible spongiform encephalopathies Estimation of epidemic size and incubation time based on age characteristics of vCJD in the United Kingdom Uncertainty due to model choice in variant Creutzfeldt-Jakob disease projections Guidance for industry: revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products Transfusion transmission of human prion diseases Transfusion-associated Chagas disease (American trypanosomiasis) in Mexico: implications for transfusion medicine in the United States Guidance for industry: use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in whole blood and blood components intended for transfusion Trypanosoma cruzi in Los Angeles and Miami blood donors: impact of evolving donor demographics on seroprevalence and implications for transfusion transmission Epidemiological and laboratory findings from 3 years of testing United States blood donors for Trypanosoma cruzi The United States Trypanosoma cruzi Infection Study: evidence for vector-borne transmission of the parasite that causes Chagas disease among United States blood donors Anthrax as a biological weapon: medical and public health management. keywords: aids; blood; disease; donors; fda; hepatitis; non; risk; safety; screening; testing; transfusion; transmission; united; virus cache: cord-274061-ynqxgyw6.txt plain text: cord-274061-ynqxgyw6.txt item: #24 of 48 id: cord-276414-kicu0tv5 author: Bahadur Gurung, Arun title: In silico screening of FDA approved drugs reveals ergotamine and dihydroergotamine as potential coronavirus main protease enzyme inhibitors date: 2020-06-10 words: 2429 flesch: 45 summary: key: cord-276414-kicu0tv5 authors: Bahadur Gurung, Arun; Ajmal Ali, Mohammad; Lee, Joongku; Abul Farah, Mohammad; Mashay Al-Anazi, Khalid title: In silico screening of FDA approved drugs reveals ergotamine and dihydroergotamine as potential coronavirus main protease enzyme inhibitors date: 2020-06-10 journal: In the present study, we have explored the possibilities of FDA approved drugs as potential inhibitors of the coronavirus main protease, a therapeutically important drug target playing a salient role in the maturation and processing of the viral polyproteins and are vital for viral replication and transcription. keywords: coronavirus; drugs; kcal; mol; sars cache: cord-276414-kicu0tv5.txt plain text: cord-276414-kicu0tv5.txt item: #25 of 48 id: cord-276460-nmugz0oh author: Katz, Louis M. title: Computer-Based Blood Donor Screening: A Status Report date: 2007-01-31 words: 7081 flesch: 41 summary: Transfusion 45s:SP202, 2005 (abstr) Cunningham KJ: Cost of quality for donor screening documentation errors Audio versus manual implementation of new questions Innovations in blood donor screening and blood collection Internet donor health history interviewing Risk-behavior reporting by blood donors with an automated telephone system The adventures of implementing a satellite base wide area network. Food and Drug Administration–cleared systems for computer-assisted self-interview of blood donors are briefly described. keywords: blood; casi; center; computer; donor; ftfi; interview; interviewing; questions; risk; screening; staff; study; system cache: cord-276460-nmugz0oh.txt plain text: cord-276460-nmugz0oh.txt item: #26 of 48 id: cord-278174-znc99yos author: Ramsey, Glenn title: Managing recalls and withdrawals of blood components date: 2004-01-31 words: 4904 flesch: 46 summary: Over the past 10 to 15 years, the stricter application of these principles to blood components has led to a growing number of recalls and withdrawals by blood suppliers, as well as a concomitant increase in the numbers of notices sent to transfusion services about blood products they have received. Furthermore, because platelets and red blood cells have a short shelf life and because hospitals do not keep a large reserve of blood components in storage, most of these notices about nonconforming blood products are often received after the units had been transfused. keywords: blood; components; donor; fda; hiv; recalls; risk; testing; transfusion; units cache: cord-278174-znc99yos.txt plain text: cord-278174-znc99yos.txt item: #27 of 48 id: cord-280040-xphxlaat author: Rutala, William A. title: Disinfection and Sterilization in Health Care Facilities An Overview and Current Issues date: 2016-09-30 words: 8374 flesch: 29 summary: Guidelines for environmental infection control in health-care facilities Disinfection and sterilization of prion-contaminated medical instruments, reply to Belay Efficacy of a washer-disinfector in eliminating healthcare-associated pathogens from surgical instruments FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices Disinfection and sterilization in healthcare facilities Guidelines for infection control in dental health-care settings-2003 Disinfection: is it time to reconsider Spaulding? Brief summary of the gastroenterology and urology devices panel meeting Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? ERCP scopes: what can we do to prevent infections? For this reason, several manufacturers have developed room disinfection units that can decontaminate environmental surfaces and objects. keywords: care; cleaning; contact; disinfection; health; hld; items; level; pathogens; patient; reprocessing; room; sterilization; surfaces; use cache: cord-280040-xphxlaat.txt plain text: cord-280040-xphxlaat.txt item: #28 of 48 id: cord-280571-ntgt5hy9 author: Ginocchio, Christine C. title: Strengths and Weaknesses of FDA-Approved/Cleared Diagnostic Devices for the Molecular Detection of Respiratory Pathogens date: 2011-05-01 words: 7524 flesch: 35 summary: Approved tests have undergone extensive analytical and clinical validations during the course of the FDA evaluations. In addition, during the first weeks of the 2009 influenza A H1N1 outbreak in the spring of 2009, multiple influenza viruses were cocirculating [5] . keywords: assay; detection; fda; influenza; laboratories; naats; respiratory; rsv; test; testing; time; tuberculosis; use; virus cache: cord-280571-ntgt5hy9.txt plain text: cord-280571-ntgt5hy9.txt item: #29 of 48 id: cord-287758-da11ypiy author: Mônica Vitalino de Almeida, Sinara title: COVID-19 therapy: what weapons do we bring into battle? date: 2020-09-10 words: 17493 flesch: 35 summary: More preclinical and clinical studies are required to prove whether dasatinib is really promising for COVID-19 patient treatment. SBV is also combined with other antiviral drugs, such as ledipasvir, velpatasvir and voxilaprevir. keywords: action; activity; antiviral; binding; cells; clinical; coronavirus; cov-2; covid-19; disease; drug; entry; fig; host; human; infection; inhibitor; mechanism; new; novel; patients; potential; pro; protein; receptor; replication; results; rna; sars; studies; study; syndrome; synthesis; targets; therapy; treatment cache: cord-287758-da11ypiy.txt plain text: cord-287758-da11ypiy.txt item: #30 of 48 id: cord-288567-1nmk9qhr author: Frieden, Ilona J. title: Management of infantile hemangiomas during the COVID pandemic date: 2020-05-16 words: 2218 flesch: 26 summary: A randomized, controlled trial of oral propranolol in infantile hemangioma Hemangeol (propranolol hydrochloride oral solution) Modalities of use of oral propranolol in proliferative infantile hemangiomas: an international survey among practitioners Chamlin SL et al Initiation and use of propranolol for infantile hemangioma: report of a consensus conference Evaluation of a modified outpatient model for using propranolol to treat infantile hemangiomas Baselga E et al Treatment of infantile haemangiomas: recommendations of a European expert group Oral propranolol in the treatment of proliferating infantile haemangiomas: British Society for Paediatric Dermatology consensus guidelines Consensus statement for the treatment of infantile haemangiomas with propranolol Limited utility of repeated vital sign monitoring during initiation of oral propranolol for complicated infantile hemangioma Propranolol in the treatment of infantile haemangiomas: lessons from the European Propranolol In the Treatment of Complicated Haemangiomas (PITCH) taskforce survey Safety and efficacy of topical timolol treatment of infantile haemangioma: a prospective trial Systemic timolol exposure following topical application to infantile hemangiomas Topical timolol maleate treatment of infantile hemangiomas The Hemangioma Investigator Group has created consensus recommendations for management of IH via telemedicine. keywords: care; infantile; propranolol; recommendations; telemedicine; treatment cache: cord-288567-1nmk9qhr.txt plain text: cord-288567-1nmk9qhr.txt item: #31 of 48 id: cord-290895-tb0xald0 author: Indu, Purushothaman title: Raltegravir, Indinavir, Tipranavir, Dolutegravir, and Etravirine against main protease and RNA-dependent RNA polymerase of SARS-CoV-2: A molecular docking and drug repurposing approach date: 2020-10-26 words: 2638 flesch: 47 summary: In this study, 3D structures of FDA approved small molecule antiviral drugs were retrieved from PubChem and unavailable 3D structures for antiviral drugs were developed using the chemical tool box Open Babel Drug repurposing strategy helps to find out the drugs for COVID-19 treatment from existing FDA approved antiviral drugs. keywords: covid-19; drugs; fda; indinavir; rdrp; sars; study cache: cord-290895-tb0xald0.txt plain text: cord-290895-tb0xald0.txt item: #32 of 48 id: cord-291626-lxa8pvt3 author: Pelfrene, E. title: Monoclonal antibodies as anti-infective products: a promising future? date: 2019-01-31 words: 3868 flesch: 22 summary: A randomized, controlled trial of ZMapp for Ebola virus infection The therapeutic monoclonal antibody market Therapeutic antibodies for infectious diseases Mortality and morbidity among infants at high risk for severe respiratory syncytial virus infection receiving prophylaxis with palivizumab: a systematic literature review and meta-analysis Bezlotoxumab for prevention of recurrent Clostridium difficile infection History of passive antibody administration for prevention and treatment of infectious diseases Therapeutic use of OKT3 monoclonal antibody for acute renal allograft rejection Monoclonal antibody therapeutics: history and future Efficient generation of monoclonal antibodies from single human B cells by single cell RT-PCR and expression vector cloning Molecular determinants of human neutralising antibodies isolated from a patient infected with Zika virus Broadly cross-reactive antibodies dominate the human B cell response against 2009 pandemic H1N1 influenza virus infection History and practice: antibodies in infectious diseases Monoclonal antibody-based therapies for microbial diseases Antibodies in infectious diseases: polyclonals, monoclonals and niche biotechnology Analysis of respiratory syncitial virus preclinical and clinical variants resistant to neutralization by monoclonal antibodies palivizumab and/or motavizumab Combination therapy using chimeric monoclonal antibodies protects mice from lethal H5N1 infection and prevents formation of escape mutants key: cord-291626-lxa8pvt3 authors: Pelfrene, E.; Mura, M.; Cavaleiro Sanches, A.; Cavaleri, M. title: Monoclonal antibodies as anti-infective products: a promising future? date: 2019-01-31 journal: Clinical Microbiology and Infection DOI: 10.1016/j.cmi.2018.04.024 sha: doc_id: 291626 cord_uid: lxa8pvt3 Abstract Background The paucity of licensed monoclonal antibodies (mAbs) in the infectious diseases arena strongly contrasts with the ready availability of these therapeutics for use in other conditions. keywords: antibodies; antibody; development; diseases; human; infections; mabs; monoclonal; therapeutic; treatment; use cache: cord-291626-lxa8pvt3.txt plain text: cord-291626-lxa8pvt3.txt item: #33 of 48 id: cord-294108-uvnh0s9r author: Dube, Taru title: Repurposed Drugs, Molecular Vaccines, Immune‐Modulators, and Nanotherapeutics to Treat and Prevent COVID‐19 Associated with SARS‐CoV‐2, a Deadly Nanovector date: 2020-10-25 words: 13897 flesch: 38 summary: COVID-19 patients seeking intensive care unit (ICU) are particularly older and more likely to carry pre-existing comorbid conditions like hypertension and related heart diseases followed by diabetes. To date, apart from the emergency use approval of the antiviral drug favilavir in China, India, Russia, and parts of the Middle East and the emergency use approval of remdesivir by the US-FDA and Japan in COVID-19 patients, there are no approved therapeutic molecules to treat the COVID-19 pandemic. keywords: care; cells; cov-2; covid-19; covid-19 patients; disease; dose; drug; efficacy; host; human; iii; infection; patients; phase; potential; protein; response; rna; safety; sars; therapeutics; treatment; trial; use; vaccine; virus cache: cord-294108-uvnh0s9r.txt plain text: cord-294108-uvnh0s9r.txt item: #34 of 48 id: cord-299323-riotkgj4 author: Seo, Yurim title: Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018) date: 2020-10-13 words: 3652 flesch: 43 summary: This study compared vaccine prescribing information and patient information leaflet languages between FDA/Centers for Disease Control and Prevention (CDC) and EMA. Harmonized vaccine approval and administration would be valuable for diseases that impact the global community, as it would lead to faster access to potentially beneficial vaccines. keywords: ema; fda; information; labeling; patient; product; vaccine cache: cord-299323-riotkgj4.txt plain text: cord-299323-riotkgj4.txt item: #35 of 48 id: cord-303865-vd3qr32o author: Gianturco, Stephanie L. title: Outsourcing facilities and their place in the U.S. drug supply chain date: 2020-08-28 words: 2842 flesch: 43 summary: key: cord-303865-vd3qr32o authors: Gianturco, Stephanie L.; Yoon, SeJeong; Yuen, Melissa V.; Mattingly, Ashlee N. title: Outsourcing facilities and their place in the U.S. drug supply chain date: 2020-08-28 journal: J Am Pharm Assoc (2003) DOI: 10.1016/j.japh.2020.07.021 sha: doc_id: 303865 cord_uid: vd3qr32o OBJECTIVE: The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. The use of outsourcing facilities to compound ready-to-use drug products is gaining traction in hospitals and other health care systems. keywords: drug; facilities; fda; outsourcing; products cache: cord-303865-vd3qr32o.txt plain text: cord-303865-vd3qr32o.txt item: #36 of 48 id: cord-304056-2bo0s0hz author: Lezotre, Pierre-Louis title: Part I State of Play and Review of Major Cooperation Initiatives date: 2014-12-31 words: 64920 flesch: 36 summary: During these first 10 years, there was a growing interest in ICH products beyond ICH countries, and ICH recognized early that harmonization within the ICH regions would not suffice. ICH harmonization activities fall into four categories. keywords: activities; asean; collaboration; committee; common; cooperation; countries; country; development; dras; drug; ema; european; exchange; fda; global; group; guidelines; harmonization; health; ich; ich guidelines; ich steering; implementation; information; integration; international; medicines; member; member states; new; order; pharmaceutical; procedure; process; products; public; quality; recommendations; regions; regulations; requirements; safety; specific; standards; states; steering; support; system; use; working cache: cord-304056-2bo0s0hz.txt plain text: cord-304056-2bo0s0hz.txt item: #37 of 48 id: cord-308284-r546ypur author: Simpson, Shmona title: Navigating facilitated regulatory pathways during a disease X pandemic date: 2020-10-23 words: 7033 flesch: 33 summary: To mitigate this, national and regional regulatory agencies generally should engage with their global regulatory counterparts and WHO Prequalification in a collaborative approach to product assessment and oversight under emergency circumstances, especially when novel outbreak etiologies and novel therapeutic and prophylactic modalities are being proffered. For products manufactured in, or used in, countries that cannot assure quality standards, WHO Prequalification is a system developed to help procurers of Prequalification eligible products determine if the products they are procuring meets international regulatory standards for product efficacy, safety and manufacturing quality. keywords: assessment; authorization; data; development; efficacy; emergency; health; pathways; product; regulatory; safety; trials; use cache: cord-308284-r546ypur.txt plain text: cord-308284-r546ypur.txt item: #38 of 48 id: cord-317720-gbi11oxx author: Lefferts, Joel A. title: Implementation of an Emergency Use Authorization Test During an Impending National Crisis date: 2020-05-14 words: 2150 flesch: 32 summary: As each swab type used in clinical laboratory testing was eventually approved for use in assays, national supplies became exhausted. As laboratories began to place orders for the RNA control, another bottleneck in the development and validation of laboratory testing became evident, as the supplier could not distribute this required material at a sufficient pace. keywords: fda; laboratories; laboratory; rna; testing; use cache: cord-317720-gbi11oxx.txt plain text: cord-317720-gbi11oxx.txt item: #39 of 48 id: cord-322915-zrjx31ev author: Demain, Arnold L title: Microbial drug discovery: 80 years of progress date: 2009-01-09 words: 11264 flesch: 36 summary: Furthermore, reports have been published on natural product inhibitors of HIV integrase obtained from among the marine ascidian alkaloids; that is, the lamellarins (produced by the mollusk Lamellaria sp.), and from terrestrial plants (Baccharis genistelloides and Achyrocline satureioides). The FAM (5-fluorouracil, adriamycin, mitomycin C) and SMF (streptozotocin, mitomycin C, 5-fluorouracil) chemotherapy regimens Mitomycin dimers: polyfunctional cross-linkers of DNA Identification of two genes from Streptomyces argillaceus encoding glycosyltransferases involved in transfer of a disaccharide during biosynthesis of the antitumor drug mithramycin GLUT2 in pancreatic islets: crucial target molecule in diabetes induced with multiple low doses of streptozotocin in mice Improved production of pentostatin and identification of fermentation cometabolites Pentostatin in T-non-Hodgkin's lymphomas: efficacy and effect on CD26+ T lymphocytes Cleavage behavior of calicheamicin gamma 1 and calicheamicin T Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia Study on the preparation and regeneration of protoplast from taxol-producing fungus Nodulisporium sylviforme Natural products as sources of new drugs over the last 25 years Epothilons A and B: antifungal and cytotoxic compounds from Sorangium cellulosum (Myxobacteria): production, physico-chemical and biological properties Epothilones, a new class of microtubulestabilizing agents with a taxol-like mechanism of action Activities of the microtubule-stabilizing agents epothilones A and B with purified tubulin and in cells resistant to paclitaxel (Taxol) keywords: acid; activity; agents; antibiotics; bacteria; cancer; cell; compounds; development; discovery; disease; drugs; gram; growth; health; hiv; human; infections; inhibitors; microbial; patients; production; products; resistance; streptomyces; treatment; use; years cache: cord-322915-zrjx31ev.txt plain text: cord-322915-zrjx31ev.txt item: #40 of 48 id: cord-326922-bajpr5a2 author: Watson, C. James title: Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors date: 2020-11-02 words: 7103 flesch: 32 summary: Supplemental Outsourced compounding can be problematic Meningitis outbreak reveals gaps in US drug regulation Regulating compounding pharmacies after NECC How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak Fungal infections associated with contaminated methylprednisolone in Tennessee Fungal infections associated with contaminated methylprednisolone injections Human drug compounding. Despite Congress's attempt to strengthen oversight of compounding pharmacies, litigation challenging FDAMA tempered the FDA's authority to regulate compounders. keywords: administration; compounding; contamination; drug; errors; facilities; fda; food; medications; outbreak; outsourcing; patients; pharmacies; pharmacy; states; united cache: cord-326922-bajpr5a2.txt plain text: cord-326922-bajpr5a2.txt item: #41 of 48 id: cord-328471-oz99upzz author: Ahmad, Jamshaid title: SARS-CoV-2 RNA Dependent RNA Polymerase (RdRp) – A drug repurposing study date: 2020-07-23 words: 5094 flesch: 50 summary: During protein preparation, different combinations of enantiomers and tautomers were generated, which ultimately enhanced the total number of drug molecules. Although, designing and developing a panel of new drugs molecules are always encouraged. keywords: binding; docking; drugs; efficiency; ligand; molecules; protein; rdrp; residues; rna; score; site cache: cord-328471-oz99upzz.txt plain text: cord-328471-oz99upzz.txt item: #42 of 48 id: cord-332038-icyut3xa author: Pillaiyar, Thanigaimalai title: A medicinal chemistry perspective of drug repositioning: Recent advances and challenges in drug discovery date: 2020-04-02 words: 11290 flesch: 33 summary: Schein Update on the management of rosacea: a status report on the current role and new horizons with topical azelaic acid Cure of condylomaacuminata covering the glans penis using aminolevulinic acid/photodynamic therapy A phase 1 study of azacitidine with high-dose cytarabine and mitoxantrone in high-risk acute myeloid leukemia Quinine an old anti-malarial drug in a modern world: role in the treatment of malaria Antiviral effects of quinine sulfate on HSV-1 HaCat cells infected: analysis of the molecular mechanisms involved Inhibition of influenza virus replication by targeting broad host cell pathways Quinoline hybrids and their antiplasmodial and antimalarial activities Evaluation of antiplasmodial potential of C2 and C8 modified quinolines: in vitro and in silico Astemizole analogues with reduced hERG inhibition as potent antimalarial compounds Liver-stage malaria parasites vulnerable to diverse chemical scaffolds New leads for drug repurposing against malaria Repurposing drugs to target the malaria parasite unfolding protein response Repositioning Salirasib as a new antimalarial agent Triazole derivatives and their antiplasmodial and antimalarial activities Antimalarial agents against both sexual and asexual parasites stages: structure-activity relationships and biological studies of the Malaria Box compound 1-[5-(4-bromo-2-chlorophenyl)furan-2-yl]-N-[(piperidin-4-yl)methyl]methanamine (MMV019918) and analogues World Alzheimer Report 2010: the global economic impact of dementia (Alzheimer's disease international The amyloid cascade hypothesis for Alzheimer's disease: an appraisal for the development of therapeutics Dendritic function of tau mediates amyloid-β toxicity in Alzheimer's disease mouse models Alzheimer's disease Aligning the evidence with practice: NICE guidelines for drug treatment of Alzheimer's disease The exploration of novel Alzheimer's therapeutic agents from the pool of FDA approved medicines using drug repositioning, enzyme inhibition and kinetic mechanism approaches The prokinetic cinitapride has no clinically relevant pharmacokinetic interaction and effect on qt during coadministration with ketoconazole Cinitapride protects against ethanol-induced gastric mucosal injury in rats: role of 5-hydroxytryptamine, prostaglandins and sulfhydryl compounds Treating Alzheimer's disease by targeting iron Tarenflurbil Phase 3 Study Group. Salirasib (72, Figure 6 ) is a promising cancer drug candidate inhibits isoprenylcysteine carboxyl methyltransferase (ICMT), a validated target for cancer drug development. keywords: acid; activity; alzheimer; amyloid; brain; cancer; cells; development; disease; drug; effects; figure; inhibition; inhibitors; leukemia; parkinson; patients; potential; repurposing; risk; studies; study; treatment; tyrosinase cache: cord-332038-icyut3xa.txt plain text: cord-332038-icyut3xa.txt item: #43 of 48 id: cord-333732-dtfmcqh6 author: Johnson, Walter G title: Legislating in the Time of a Pandemic: Window of Opportunity or Invitation for Recklessness? date: 2020-06-15 words: 2866 flesch: 38 summary: The COVID-19 pandemic has created such a policy window for reforming U.S. diagnostics regulation, a debate which had been sputtering for several years but had been unable to get across the finishing line. In response to these problems, two bills have been introduced in Congress to not only reform emergency use of diagnostic tests, but to fundamentally reform diagnostics regulation in non-emergencies. keywords: act; crisis; diagnostics; emergency; fda; regulation; testing cache: cord-333732-dtfmcqh6.txt plain text: cord-333732-dtfmcqh6.txt item: #44 of 48 id: cord-334847-lf1grybz author: Lynch, Holly Fernandez title: Regulatory Flexibility for COVID-19 Research date: 2020-07-07 words: 2020 flesch: 30 summary: COVID-19 research has been running at a remarkable pace,(3) challenging the capacity of both investigators and institutional review boards (IRBs). This has traditionally been a lengthy process, often involving face-to-face contact with stakeholders, which will be difficult for COVID-19 research given urgency and the likely need to continue physical distancing for some time. keywords: covid-19; fda; irb; irbs; research; review cache: cord-334847-lf1grybz.txt plain text: cord-334847-lf1grybz.txt item: #45 of 48 id: cord-335776-e5wjsk8t author: Costantino, Ryan C. title: The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist date: 2020-08-18 words: 3606 flesch: 37 summary: It is estimated that 90% of Americans benefit from generic medications, thanks to the groundbreaking Hatch-Waxman Act, which reduced barriers to accessing medications worldwide. Despite years of effort raising concerns about the USPSC, pharmacists and pharmacy technicians continue to spend a substantial amount of time and energy responding to, and mitigating the impact of, medication shortages, drug recalls, and the adverse outcomes related to low-quality medications. keywords: drug; fda; medications; pharmaceutical; pharmacists; quality; safety; supply; u.s cache: cord-335776-e5wjsk8t.txt plain text: cord-335776-e5wjsk8t.txt item: #46 of 48 id: cord-339122-7vvqtk84 author: Deb, Chaarushena title: Covid-19, Single-Sourced Diagnostic Tests, and Innovation Policy date: 2020-07-07 words: 3118 flesch: 45 summary: We first summarize (A) a recent history of diagnostic test patentability, since patents have both created incentives but hampered access and clinical practice; (B) describe current efforts to increase diagnostic test patents; and then (C) propose improved reimbursement mechanisms as a solution to the balancing act of managing appropriate economic incentives and allowing for optimal clinical practice during non-emergent conditions. We thus argue against relying too heavily on exclusivity-creating patents as innovation incentive for diagnostic tests—including the proposed Coons-Tillis patent reform bill which would increase patentability for many such tests. keywords: development; diagnostic; pandemic; patent; sourcing; testing; tests cache: cord-339122-7vvqtk84.txt plain text: cord-339122-7vvqtk84.txt item: #47 of 48 id: cord-352579-ndcbmgfj author: Takahashi, Takuto title: Pharmacogenomics of COVID-19 therapies date: 2020-08-18 words: 5264 flesch: 28 summary: In conclusion, although direct evidence in COVID-19 patients is lacking, we identified potential actionable genetic markers in COVID-19 therapies. Clinical studies in COVID-19 patients are deemed warranted to assess potential roles of these markers. keywords: azithromycin; covid-19; drug; hydroxychloroquine; lopinavir; patients; pharmacogenomics; ribavirin; risk; tocilizumab; treatment; use; variants cache: cord-352579-ndcbmgfj.txt plain text: cord-352579-ndcbmgfj.txt item: #48 of 48 id: cord-354445-lnvc7mmf author: Lichtenstein, David title: 4 Cleaning and Disinfecting Gastrointestinal Endoscopy Equipment date: 2019-12-31 words: 13660 flesch: 32 summary: An investigation using molecular epidemiology A prospective analysis of fever and bacteremia following ERCP Polymicrobial sepsis following endoscopic retrograde cholangiopancreatography Infection control practices in gastrointestinal endoscopy in the United States: a national survey Iatrogenic Campylobacter pylori infection is a cause of epidemic achlorhydria Development and validation of rapid use scope test strips (RUST) to determine the efficacy of manual cleaning for flexible endoscope channels Rapid method for the sensitive detection of protein contamination on surgical instruments The ATP test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels Validation of ATP to audit manual cleaning of flexible endoscope channels Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines Assessing residual contamination and damage inside flexible endoscopes over time Simulated-use validation of a sponge ATP method for determining the adequacy of manual cleaning of endoscope channels Validation and comparison of three adenosine triphosphate luminometers for monitoring hospital surface sanitization: a Rosetta Stone for adenosine triphosphate testing The use of rapid indicators for the detection of organic residues on clinically used gastrointestinal endoscopes with and without visually apparent debris The compliance of reprocessing personnel with endoscope reprocessing protocols should be reviewed at least annually to document ongoing competency. keywords: channels; cleaning; control; devices; disinfection; duodenoscopes; endoscope; fda; guidelines; health; hld; level; manual; patient; procedures; reprocessing; risk; sterilization; time; transmission; use; water cache: cord-354445-lnvc7mmf.txt plain text: cord-354445-lnvc7mmf.txt