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.
FDA, United States