Results 141 to 150 of about 22,069,849 (289)

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

Autonomy without immunity: conventionality control and the limits of sporting sovereignty in the Inter-American system. [PDF]

open access: yesFront Sports Act Living
Cruz-Núñez RL   +3 more
europepmc   +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

Phase 1, open‐label, randomized study of the elecoglipron pharmacokinetic profile in healthy participants under fed and fasted conditions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Elecoglipron (AZD5004/ECC5004) is an oral small‐molecule glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) in development for weight management in people living with obesity or overweight and type 2 diabetes. This study aimed to characterize the pharmacokinetics (PK) profiles of two formulations of elecoglipron under fed and fasted conditions ...
Jianfeng Xu   +13 more
wiley   +1 more source

Defining a comprehensive set of value assessment criteria for funders of drug repurposing initiatives

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aims to develop a structured list of value assessment criteria for drug repurposing (DR) projects designed to support consistent, evidence‐informed decision‐making by funders. The assessment criteria were developed within the REMEDi4ALL project, a multi‐stakeholder Horizon Europe funded initiative to advance DR and were validated ...
Dalma Hosszú   +10 more
wiley   +1 more source

Life as an ethnic minority (EM) university student: Comparing mental health challenges among local and international EM students in Hong Kong

open access: yesBritish Educational Research Journal, EarlyView.
Abstract University students globally face growing mental health challenges, with ethnic minority (EM) students—both local and international—being particularly vulnerable. Yet, limited research compares their experiences or identifies shared and distinct stressors, especially in non‐Western contexts.
Wang Xinyi, Naubahar Sharif
wiley   +1 more source

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