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