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Biopharmaceutic studies

(Previously Guidance 15: Biopharmaceutic studies)

16 December 2019

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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:
    • 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.


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