The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized - Default - 510_6160ecec172b6

ICH Guideline for Biopharmaceutics Classification System- Based Biowaiver (M9): Toward Harmonization in Latin American Countries

ICH Guideline for Biopharmaceutics Classification System- Based Biowaiver (M9): Toward Harmonization in Latin American Countries

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The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized

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