[医药卫生]_3 CMC Workshop Stability S-Colgan.pdf

Stability Studies for Drug Registrations AAPS/CPA CMC Workshop: Quality, Regulatory and Scientific Requirements and Strategies Shanghai, June 2010 Stephen T. Colgan, Ph.D. Pfizer Global Research and Development 0 谢谢你的邀请 在此化学质量控制研讨会发言 这是我第一次访问中国 我非常高兴能在这里！ Pfizer • Internal Use Pfizer Global Research and Development 1 Concepts that will be discussed Include….. Concepts that will be discussed Include….. The Scientific and Regulatory Objectives for Stability Studies – Specific Issues related to API and DP Stability Programs Current Regulatory Guidance on Stability – (Focus on Registration Stability) Stability Design Options – Bracketing and Matrixing Strategies – Other Science-based Testing Protocols Stability Studies for Clinical Trials/Marketing Applications/ Generics and Line Extensions Pfizer • Internal Use Pfizer Global Research and Development 2 Concepts that will be discussed Include….. Concepts that will be discussed Include….. Appropriate use of Extrapolation to set – Clinical Use-Periods and Commercial Shelf Life for Drug Product – Re-test periods for Drug Substance Stability-Related Regulatory Queries Emerging Stability Issues Stability-Related Resources Pfizer • Internal Use Pfizer Global Research and Development 3 Take Home Messages Take Home Messages Stability Studies are conducted for many reasons – To support Clinical Trials/Marketing Applications/Post approval Changes – To determine expiry or retest