Zdrowie i gospodarka · 09/12/2014
FDA Releases Draft Guidance on Pediatric Clinical Pharmacology Studies for New Drugs and Biologics
The FDA has released a draft guidance to help pharmaceutical companies design clinical trials in pediatric populations, focusing on gathering information about a drug's pharmacokinetics and pharmacodynamics to ensure safe and effective dosing.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →