Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment

Background: In 2005, the European Medicines Agency (EMA) released guidance on pharmacokinetic studies in patients with hepatic impairment. This guidance describes the design of these studies and what information should be presented in the Summary of Product Characteristics (SmPC). We aim to evaluate...

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Detalles Bibliográficos
Autores principales: Weersink, Rianne A., Timmermans, Lotte, Monster-Simons, Margje H., Mol, Peter G. M., Metselaar, Herold J., Borgsteede, Sander D., Taxis, Katja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6758592/
https://www.ncbi.nlm.nih.gov/pubmed/31607904
http://dx.doi.org/10.3389/fphar.2019.01031

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6758592/
https://www.ncbi.nlm.nih.gov/pubmed/31607904
http://dx.doi.org/10.3389/fphar.2019.01031

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