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(Previously Guidance 15: Biopharmaceutic studies)
Version 1.2 December 2019
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:
- 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.