Biopharmaceutics Classification System-based biowaivers
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is announcing the availability of a final endorsed concept paper entitled “M9: Biopharmaceutics Classification System-based Biowaivers"
This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies.
M9 Concept Paper and Business Plan
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