Results 181 to 190 of about 5,895,005 (299)

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad   +4 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

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

Lithium‐related adverse drug reactions in children: A case–control study comparing lithium to second‐generation antipsychotics in VigiBase

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to improve the understanding of lithium's safety profile by analysing the frequency and distribution of reported adverse drug reactions (ADRs) compared to second‐generation antipsychotics (SGAs). Methods Individual case safety reports from VigiBase (1968–October 2023) involving individuals older than 2 years, with lithium or SGAs ...
Lisa T. Ringeling   +8 more
wiley   +1 more source

Pharmacokinetics and safety of a modified‐release psilocybin formulation: A SAD Phase I trial in normal‐weight and overweight/obese participants

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified‐release psilocybin formulation (REL‐P11) in normal‐weight and overweight/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic ...
Anna Signor   +11 more
wiley   +1 more source

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