Results 141 to 150 of about 91,140 (235)

Capability Development in the European Medicines Regulatory Network—A European Learning Needs Analysis and Survey Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision‐making.
Naomi Beard   +4 more
wiley   +1 more source

Maternal‐to‐Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
This review evaluates the available pharmacokinetic data on the plasma‐to‐breastmilk transfer of first‐ and second‐line T2DM drugs against available clinical guideline recommendations. A list of drug therapies for treating T2DM was generated from national and international clinical guidelines.
Katherine Richardson   +4 more
wiley   +1 more source

More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Traditionally, clinical outcomes measuring how a patient feels, functions, or survives are preferred endpoints in clinical trials; however, some may take a long time to manifest in slowly developing diseases. Biomarkers, if properly validated, can serve as surrogate endpoints, acting as substitutes for clinical outcomes.
Renske Johanna Grupstra   +4 more
wiley   +1 more source

A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Regional differences in approved drug dosages and administration are shaped by complex factors, including clinical data, prior regulatory decisions, and region‐specific considerations. This study investigated how such factors are associated with variations in approved doses across the United States Food and Drug Administration (FDA), European Medicines
Sachiko Mita, Shunsuke Ono
wiley   +1 more source

EMA – Publication of the EMA’s 2024 annual report

open access: yes
EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures.
openaire   +2 more sources

Population Pharmacokinetics of Dupilumab in Adults, Adolescents, and Children With Eosinophilic Esophagitis

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Dupilumab, a fully human monoclonal antibody that blocks key drivers of type 2 inflammation, is approved across 8 diseases, including eosinophilic esophagitis. Subcutaneous dupilumab 300 mg weekly improved outcomes vs. placebo in adults (aged ≥ 18 years) and adolescents (aged ≥ 12 to < 18 years) during the phase III LIBERTY EoE TREET study (NCT03633617)
Jenny‐Hoa Nguyen   +8 more
wiley   +1 more source

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