Results 151 to 160 of about 51,185 (287)

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Association of sleep efficiency with cardiac autonomic modulation in young and professional soccer players during pre-season. [PDF]

open access: yesSleep Breath
Oliveira NG   +14 more
europepmc   +1 more source

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

open access: yesBritish 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   +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

Efficacy of afoxolaner or a combination of afoxolaner and milbemycin oxime against fleas, ticks, lice and/or intestinal nematodes in dogs naturally infested in two urban areas in Brazil. [PDF]

open access: yesParasit Vectors
Cutolo AA   +9 more
europepmc   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink   +21 more
wiley   +1 more source

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