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药物杂质：简略新药申请的监管视角

Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.

作者信息

Basak Arup K, Raw Andre S, Al Hakim Ali H, Furness Scott, Samaan Nashed I, Gill Devinder S, Patel Hasmukh B, Powers Roslyn F, Yu Lawrence

机构信息

Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA.

出版信息

Adv Drug Deliv Rev. 2007 Jan 10;59(1):64-72. doi: 10.1016/j.addr.2006.10.010. Epub 2006 Nov 15.

DOI:10.1016/j.addr.2006.10.010

PMID:17196703

Abstract

Impurities in drug substances and drug products have been important regulatory issues in the Office of Generic Drugs by having significant impact on the approvability of Abbreviated New Drug Application (ANDAs). This review begins with a discussion of ANDAs and its similarity/differences with NDAs, highlighting the importance of control of pharmaceutical impurities in generic drug product development and regulatory assessment. An overview of the FDA draft guidance documents "ANDAs: Impurities in Drug Substances" and "ANDAs: Impurities in Drug Products" are provided. This introduces the identification and qualification procedures for ANDAs and approaches to the establishment of acceptance criteria for both drug substance and drug product. Case studies included in this review illustrate the proposed pathway for determination of impurities and their acceptance criteria, based upon the general principles of these guidances.

摘要

原料药和药品中的杂质一直是仿制药办公室重要的监管问题，因为它们对简略新药申请（ANDA）的获批可能性有重大影响。本综述首先讨论了ANDA及其与新药申请（NDA）的异同，强调了在仿制药产品开发和监管评估中控制药物杂质的重要性。提供了美国食品药品监督管理局（FDA）指导文件草案“ANDA：原料药中的杂质”和“ANDA：药品中的杂质”的概述。这介绍了ANDA的识别和鉴定程序以及确定原料药和药品接受标准的方法。本综述中的案例研究说明了基于这些指导原则确定杂质及其接受标准的建议途径。