Transcription of Draft Note Guidance Investigation Bioavailability ...
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Draft Note Guidance Investigation Bioavailability ...
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 14 December 2000. CPMP/EWP/QWP/1401/98. COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS. (CPMP). NOTE FOR Guidance ON. THE Investigation OF Bioavailability AND. BIOEQUIVALENCE. DISCUSSION IN THE JOINT EFFICACY AND QUALITY December 1997- WORKING GROUP October 1998. TRANSMISSION TO THE CPMP July 1998. RELEASE FOR CONSULTATION December 1998. DEADLINE FOR COMMENTS June 1999. DISCUSSION IN THE DRAFTING GROUP February May 2000. TRANSMISSION TO THE CPMP July - December 2000. RELEASE FOR CONSULTATION December 2000. DEADLINE FOR COMMENTS March 2001. Note: This revised Note for Guidance will replace the previous guideline adopted in December 1991.
33 • Clinical Requirements for Locally Applied, Locally Acting Products Containing 34 Known Constituents. 35 • The Investigation of Drug Interactions 36 • Development Pharmaceutics 37 • Process Validation 38 • Manufacture of the Finished Dosage Form 39 • Validation of analytical procedures: Definitions and Terminology (ICH topic Q2A)
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