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Clinical Supplies and Their Stability Evaluation – Scientific Insights for Drug Development and Regulatory Expectations in U.S. and E.U.
Wednesday, November 14
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-526-L04
Thorough stability evaluation of clinical supplies and development batches of drug substances and drug products are critical during the development stages beyond the minimum regulatory requirements. Critical evaluation of stability data of the drug products and drug substances provide insights into performance of analytical methods, drug product formulations, processes for drug substance and drug product manufacture and are major contributors to the continued drug development process. This symposium will address the regulatory requirements for stability evaluation of clinical supplies in U.S. and E.U., need for critical stability evaluation beyond the minimum requirements, evolution of specification during development phases and how effective utilization of stability data can contribute to accelerated drug development process. Critical stability evaluation during development stages – importance to accelerated drug development beyond regulatory requirements
Moderator
Dilip R. Choudhury, Ph.D.
Scios, Inc./Johnson & Johnson
Critical Stability Evaluation During Development Phases – Importance to Accelerated Drug Development Beyond Regulatory Requirements
Dilip R. Choudhury, Ph.D.
Scios, Inc./Johnson & Johnson
Evolution of Specifications from Early Clinical Development Phases Through Registration – U.S. and E.U. Perspectives
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals