Transcription of Biopharmaceutics Classification System-Based Biowaivers
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Biopharmaceutics Classification System-Based Biowaivers
10 February 2020. EMA/CHMP/ICH/493213/2018. Committee for Medicinal Products for Human Use ICH M9 guideline on Biopharmaceutics Classification System-Based Biowaivers Step 5. Transmission to CHMP 25 July 2018. Adoption by CHMP for release for consultation 25 July 2018. Start of consultation 26 July 2018. Deadline for comments 26 January 2019. Final adoption by CHMP 30 January 2020. Date for coming into effect 30 July 2020. Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 An agency of the European Union European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
substances and the BCS-based biowaiver of bioequivalence studies for drug products. The BCS-based biowaiver principles may be applied to bioequivalence purposes not explicitly specified in the guideline, provided they can be supported by a thorough scientific rationale. 1.2. Scope . BCS-based biowaivers may be used to substantiate . in vivo ...
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