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

Claudia Miranda1, Alexis Aceituno2,3, Mirna Fernández4

  • 1Centro de Bioactivos Químicos, Unit of Modeling & Experimental Biopharmaceutics, Universidad Central "Marta Abreu" de Las Villas, 54830 Santa Clara, Cuba.

Pharmaceutics
|April 3, 2021
PubMed
Summary

The Biopharmaceutical Classification System (BCS) aids in replacing in vivo studies with in vitro assays for multisource products. Harmonizing BCS guidelines in Latin America is crucial for developing safe, effective generic drugs and improving patient access.

Keywords:
BCSLatin Americabioequivalencebiowaiverdissolutionmultisource drug

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