Results 211 to 220 of about 2,963,114 (289)

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh   +19 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm   +2 more
wiley   +1 more source

Exposure to CYP2C19‐metabolized drugs following acute stroke: A longitudinal cohort study to inform implementation of CYP2C19 genotype testing

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Cytochrome P450 2C19 (CYP2C19) genotype testing is recommended to guide antiplatelet selection after ischaemic stroke and transient ischaemic attack. CYP2C19 also metabolizes several commonly prescribed non‐antiplatelet drugs. We aimed to quantify exposure to CYP2C19‐metabolized drugs in stroke patients at hospital discharge and during ...
Cleodie C. Swire   +3 more
wiley   +1 more source

Perceived professional competence of clinical research coordinators. [PDF]

open access: yesJ Clin Transl Sci, 2020
Rojewski JW   +6 more
europepmc   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang   +5 more
wiley   +1 more source

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