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Bioavailability of Dietary Supplements: Key Issues in Defining the Research Agenda Impact of Formulation on Bioavailability? Discussion Leader: Stephen W. Hoag Ph.D. University of Maryland Rapporteur: Ajaz S. Hussain, Ph.D. CDER, FDA Preface Introductions Background – Pharmaceutical Sciences – Nutritional Sciences – Nutraceuitical Sciences – Pharmaceutical formulations, bioavailability and bioequivalence – Food and Dietary Supplements – formulations, bioavailability, and bioequivalence Questions for considerations Key issues in defining the research agenda? – What is the question? • Do two different pharmaceutical products containing the same drug provide the same “safety” and “efficacy” profile? – What are we willing to assume? • Drug concentration time profile in plasma is a reliable surrogate for safety and efficacy profile – How sure do we want to be? • The 90% confidence interval of the ratio of the peak concentration of drug in plasma, time to reach the peak concentration, and the area under the curve are within 80125% Key Topics Discussed Product Classification System Identification of “Critical Variables” – Interactions – Modulation of Bioavailability – In vitro methods for assessing dissolution & absorption – Product Comparison – Optimal Product Use Goals and Objectives Improving Public Health – Better products – Safety Enhance Scientific Knowledge Develop General Methods for: – Formulation – Testing Define Quality Standards Prioritization – Health Issues – Market Prevalence Identification of “Critical Formulation Variables” For a given class – Critical Process and formulation variables that significantly impact • Bioavaiable • Stability General strategies and/or methods need to be developed for formulation optimization of nutritional supplements Data for Public Domain use – Improve quality and safety through better practices In vitro methods for assessing dissolution & Absorption USP Dissolution Caco2 Etc. Product Comparison “Bioequivalence” Comparison of bioavailability of different product types (including food) – Information for consumers and clinicians Example – Natural vs. synthetic • Ca supplements – Units of activity measurement