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

• Main Authors: Rianne A. Weersink (Author), Lotte Timmermans (Author), Margje H. Monster-Simons (Author), Peter G. M. Mol (Author), Herold J. Metselaar (Author), Sander D. Borgsteede (Author), Katja Taxis (Author)
• Format: Book
• Published: Frontiers Media S.A., 2019-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...