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

• 主要な著者: Rianne A. Weersink (著者), Lotte Timmermans (著者), Margje H. Monster-Simons (著者), Peter G. M. Mol (著者), Herold J. Metselaar (著者), Sander D. Borgsteede (著者), Katja Taxis (著者)
• フォーマット: 図書
• 出版事項: Frontiers Media S.A., 2019-09-01T00:00:00Z.
• 主題: article
• オンライン･アクセス: 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...