Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1

Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1

GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE

Leitlinie

This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence" CPMP/EWP/QWP/1401/98 and the related questions in the Q&A document (EMEA/CHMP/EWP/40326/2006). This guideline includes recommendations on BCS-based biowaivers.