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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.

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