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ICH M9 BCS-Based Biowaivers
Session Chair(s)
Roger Nosal, PhD
Vice President, Head of 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.
Speaker(s)
ICH M9 BCS Based Biowaivers: Progress and Challenges
Roger Nosal, PhD
Pfizer Inc, United States
Vice President, Head of Global CMC
Revisiting Classification Criteria for Demonstrating Solubility, Permeability, and Comparative Dissolution
Paul Seo, PhD
FDA, United States
Director, Division of Biopharmaceutics, ONDP, OPQ, CDER
Regional Challenges for Comparative Dissolution and Post-Approval Changes: Excipients
Talia Flanagan, PhD
UCB, United Kingdom
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