Results 211 to 220 of about 1,894,306 (293)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Evaluating and leveraging large language models in clinical pharmacology and therapeutics assessment: From exam takers to exam shapers

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims In medical education, the ability of large language models (LLMs) to match human performance raises questions about their potential as educational tools. This study evaluates LLMs' performance on Clinical Pharmacology and Therapeutics (CPT) exams, comparing their results to medical students and exploring their ability to identify poorly formulated
Alexandre O. Gérard   +11 more
wiley   +1 more source

Evaluation of the Medicines and Healthcare products Regulatory Agency's introduction of a risk‐proportionate approach for clinical trials: An analysis of 4617 applications assessed between September 2023 and August 2024

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The Medicines and Healthcare products Regulatory Agency (MHRA) introduced a risk‐proportionate approach to assess clinical trial applications for authorisation in August 2023. This study evaluates the impact of this approach on the timelines for reviewing proposals.
Andrea Manfrin   +6 more
wiley   +1 more source

Low‐intervention clinical trials in Spain: Do they progress?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza   +4 more
wiley   +1 more source

Governing AI in Mental Health: 50-State Legislative Review.

open access: yesJMIR Ment Health
Shumate JN   +7 more
europepmc   +1 more source

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