BCS分类相关定义.pdf

/10.14227/DT180111P31 Biopharmaceutics Classification System: A Regulatory Approach B. Basanta Kumar Reddy1,* and A. Karunakar2 e-mail: bbasanthdreddy@ 1 Regulatory Affair Dpt., Indchemie Health Specialities Pvt. Ltd., (Alkem Research Laboratory), M.I.D.C, Taloja, Dist-Raigarh, Navi Mumbai Maharashtra-410208, India 2Regulatory Affair Department, IPDO, Dr. Reddy’s Laboratory, Bachupally, Hyderabad, Andhra Pradesh-502325, India ABSTRACT The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal tract (GIT) for NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filings and biowaivers. This step reduces timelines in the new drug development process, both directly and indirectly, reduces unnecessary drug exposure in healthy volunteers, and increases impact for the replacement of certain bioequivalence (BE) studies with in vitro dissolution tests. INTRODUCTION OBJECTIVES AND CONCEPT OF BCS n ANDA (21 CFR 314) contains data for the review The objectives of the BCS are (2): and ultimate approval of a generic drug product. • To improve the efficiency of the drug development AGeneric drug applications are termed “abbreviated” and review process by recommending a strategy for because they generally are not required to i