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Held in conjunction with CRO/Sponsor Summit on Data Integrity in Clinical Research
19 Jul 2016 - 20 Jul 2016, at 9.00 am to 5.00 pm in Hyderabad
Two pharmaceutical formulations are considered bioequivalent (BE) when their respective rate and extent of bioavailability (BA) following administration of a unit dose under standard clinical conditions are substantially similar. Statements regarding bioavailability and bioequivalence appear to be simple and straightforward, however, have given rise to considerable controversy in pharmaceutical and clinical circles for many years which are compounded by economic factors associated with establishing bio- and therapeutic equivalence. Numerous rules and global regulations have been issued and equal, if not more, number of interpretations and opinions have been reported primarily due to our insufficient understanding of the scope and depth of fundamental considerations associated with pharmaceutical bioequivalence. Challenges, more than often, surface while designing bioequivalence investigations for complex generic formulations. While generic bioequivalence that is strictly based on similar bio-efficacy between two formulations, their respective clinical et therapeutic equivalence is more desirable, thus, designing a bioequivalence investigation with clinical endpoint assessment seems to be emerging as an assessment tool for generic equivalence between two products. Despite complying with the global regulatory requirements, various regulatory agencies seek further clarifications in the submissions in the data of a “successful” bioequivalence investigations. To address such challenges, one has to adopt an ‘out of the box’ approache(s) that are scientifically sound and are convincing and compelling. This 2-day intensive program presents global perspectives – regulatory and technical – addressing the various challenges in designing, conducting and presenting successful BA/BE investigations including providing satisfactory and convincing rationale for queries from various regulatory agencies post submission of results/data through a judicial blend of technical information and case studies Agenda Day 1 (July 19, 2016) 9.00 AM-1.00 PM (Tea Breaks 10.30-10.45 AM) • Introduction • BA and BE: Fundamentals and Comprehensive understanding • Worldwide Regulatory Requirements for Demonstrating BE 2.00 PM-5.00 PM (Tea Breaks 3.30-3.45 PM) • Global Regulations: Requirements versus Expectations • Biopharmaceutics Classification System (BCS) and BE • Computation of PK Parameters Relevant to BA/BE Day 2 (July 20, 2016) 9.00 AM-1.00 PM (Tea Breaks 10.30-10.45 AM) • Challenges in BE Studies: Complex Generics • IVIVC Relevant to BE of Generic Formulations • Performance Based Correlations: Clinical Equivalence 2.00 PM-5.00 PM (Tea Breaks 3.30-3.45 PM) • Biowaivers: Rationale, Strategies and Applications • Discussion and QA Session
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