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ICH M9: BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS

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The ICH M9 Guideline Q&As provides recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies. This Guideline will reduce the costs and time of development and prevent unnecessary exposure of mostly healthy volunteers to medicinal products, as in vivo studies to prove the biopharmaceutical quality of the medicinal product would not be needed, and therefore, facilitate the patient’s access to medicines or post-approval changes.

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