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ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective

Philip Bransford1, Jack Cook2, Manish Gupta3

  • 1Vertex Pharmaceuticals Incorporated , 50 Northern Avenue , Boston , Massachusetts 02210 , United States.

Molecular Pharmaceutics
|December 18, 2019
PubMed

Keywords:
bioequivalence (BE)biopharmaceutics classification system (BCS)biowaiverdissolutionpermeabilityregulatorysolubility

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