Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
Title:
Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
Short Title:
NOTE FOR GUIDANCE ON
Origin/Publisher:
EMEA
Document Type:
Note for Guidance
Content:
It is the objective of this guidance to define, for products with a systemic effect, when
bioavailability or bioequivalence studies are necessary and to formulate requirements for their
design, conduct, and evaluation. The possibility of using in vitro instead of in vivo studies
with pharmacokinetic end points is also envisaged.