Published on
January 31, 2025
- 21:18 GMT
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Docket Number: FDA-1999-D-0063 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to sponsors and applicants who plan to conduct studies to assess …
Distribution channels:
Healthcare & Pharmaceuticals Industry
