Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
Titel:
Eudralex Volume 3 NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE CPMP/EWP/QWP/1401/98
Kurztitel:
NOTE FOR GUIDANCE ON
Internet:
Herkunft/Verlag:
EMEA
Dokumentenart:
Note for Guidance
Inhalt:
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.