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. Any comments should be sent to the EMEA, EWP Secretariat (Fax No. 44-20-74188613). before the end of March 2001. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK.
21 bioavailability or bioequivalence studies are necessary and to formulate requirements for their 22 design, conduct, and evaluation. The possibility of using in vitro instead of in vivo studies 23 with pharmacokinetic end points is also envisaged. 24 This guideline should be read in conjunction with Directive 75-318/EEC, as amended, and
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