Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1
Title:
Eudralex Volume 3 Guideline on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/140/98 Rev. 1
Short Title:
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
Origin/Publisher:
EMEA
Document Type:
Guideline
Content:
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.