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DIA 2018 Global Annual Meeting

ICH M9 BCS-Based Biowaivers

    Session Chair(s)
      Roger  Nosal

      Roger Nosal

      • Vice President, Global CMC
      • Pfizer Inc., United States
    The ICH M9 Expert Working Group has developed a preliminary draft of a harmonized guideline for BCS-Based Biowaivers that focuses on standardizing Biopharmaceutics Classification System criteria for demonstrating solubility, permeability/absorption, other pharmacological attributes and in vitro comparative dissolution. This session will provide a summary of the objectives for establishing a harmonized guideline that will be applicable globally and highlight current contentious issues to be resolved including: • Solubility: Highest Strength vs. Highest Therapeutic Dose • Permeability: Applicability of in vitro data (Caco-2) • Dissolution Comparability: Establishing Harmonized Conditions & Methodology Criteria • Formulation Similarity: Product Composition Applicability & Influence of Excipients This session will highlight regional challenges and differences and opportunities for harmonized reconciliation.
    Learning Objective : Describe the current challenges related to biowaivers and the progress and potential of the future ICH M9 guideline.
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States