EN PL

EMA: Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals

15.05.2014
The current guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A) contains concise statements on the type of animal pharmacokinetic data that are needed for the safety evaluation. The aim of this Q&A document is to provide clarification on the views of the CHMP on how to obtain information on pharmacokinetics from other sources.