Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **
Titel:
Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **
Kurztitel:
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
Internet:
Herkunft/Verlag:
EMEA
Dokumentenart:
Leitlinie
Inhalt:
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.