Results 181 to 190 of about 564,896 (302)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Inspection Checklist for Biocontainment: Plant Containment Laboratories (7 CFR 331; BMBL 6th Edition)

Compliance checklist for biocontainment plant ...

core  

Development of implementation strategies for the National Emergency Airway Registry for Pediatric Emergency Medicine (NEAR4PEM) pre-intubation checklist: a prospective, pre-implementation planning study. [PDF]

Implement Sci Commun
Wing R, Albanese AM, Prieto MM, Greenwald E, Harwayne-Gidansky I, Nagler J, Goldman MP, Tanzer JR, Miller K, Napolitano N, Nishisaki A.   +10 more
europepmc   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Inspection Checklist for Incident Response (7 CFR 331, 9 CFR 121, 42 CFR 73)

Compliance inspection Checklist for Incident ...

core  

Acceptability of a Large Language Model (LLM)-Generated Guideline-Based Checklist Among Otolaryngologists: A Cross-Sectional Survey and Thematic Analysis. [PDF]

Cureus
Iqbal S, Ahmadi M, Ahmadian D, Eskander P.   +3 more
europepmc   +1 more source

Systematic review and scoring‐based selection of pharmacokinetic models for precision dosing of vancomycin in neonates and children

British Journal of Clinical Pharmacology, EarlyView.
This systematic review identified 112 population pharmacokinetic models of vancomycin in neonates and children. To support rational model selection for model‐informed precision, we developed and applied expert‐driven, transparent criteria that integrate both methodological rigour and clinical relevance.
Zoë Vander Elst, Pieter‐Jan Spiessens, Dorian Vanneste, Nada Dia, Matthias Gijsen, Isabel Spriet, Karel Allegaert, Erwin Dreesen, Anne Smits   +8 more
wiley   +1 more source

Application of a Nursing Quality Improvement Checklist in the Emergency Treatment of Trauma Patients. [PDF]

Risk Manag Healthc Policy
Fan L, Zhang L, Huang Q, Deng M, Guo W, Chang D, Yuan Y, Zhou Y, Bi B, Kang Y.   +9 more
europepmc   +1 more source

Quality indicators for safe and effective medication use in long‐term care facilities: A modified Delphi study

British Journal of Clinical Pharmacology, EarlyView.
Aim This modified Delphi study aimed to achieve expert agreement on quality indicators (QIs) suitable for application at the population level, to evaluate quality use of medications and pharmacist services in long‐term care facilities (LTCFs). Methods We conducted a two‐round modified online Delphi study with a multidisciplinary panel of Australian ...
Daria S. Gutteridge, Sara Javanparast, Annabel H. Calder, Gillian E. Caughey, Andrew C. Stafford, Gregory M. Peterson, Maria C. Inacio, Peter D. Hibbert, Elizabeth Manias, Jodie B. Hillen, Janet K. Sluggett   +10 more
wiley   +1 more source

Reporting Horizon Scanning Studies: Prototype Development Study. [PDF]

J Med Internet Res
Garcia Gonzalez-Moral S, Fairweather M, Khan S, Fairbairn R, Norman G.   +4 more
europepmc   +1 more source