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.