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 (3BS11A), adopted

The current guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A) [1] contains concise statements on the type of animal pharmacokinetic data that are needed for the safety evaluation. This is a Commission guideline which was issued in October 1983.