Biopharmaceutic studies

Version 1.2 December 2019

Introduction

This guidance is intended to assist sponsors with applications for market authorisation of medicines that require demonstration of bioavailability and bioequivalence.

This guidance covers:

• all matters relating to bioavailability and/or bioequivalence aspects of medicines containing active substances that are synthetic chemical entities
• active substances that are:
  • antibiotics
  • short-chain synthetic polypeptides
• some hormones (steroid hormones and synthetic peptides of usually less than 32 amino acids-some exceptions may apply).

This guidance does not cover:

• Matters relating to other pharmacokinetic studies.

Contents