美国食品药品监督管理局评估的缩写新药申请中常见的化学、制造和控制缺陷:获得成本效益高的药物的障碍

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Samruddhi B. Kulkarni , Vinod L. Gaikwad
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引用次数: 0

摘要

要在美国销售仿制药,必须在美国食品药品监督管理局以通用技术文件(CTD)格式注册。《仿制药使用费法案》于2012年生效,旨在通过在审查周期的不同时间间隔通过缺陷函向申请人传达申请中的潜在缺陷,加快对缩写新药申请(ANDA)的及时审查。这通常会延迟产品批准,因为在批准产品之前必须解决这些缺陷。在本研究中,进行了一项研究,以分析2013年至2020年CTD质量模块中ANDA应用程序的重复查询,并起草了可能采取的纠正和预防措施。最常见的查询出现在标题为“制造工艺和工艺控制说明”、“关键步骤和中间体的控制”、“规格(药品控制)”和“稳定性数据”的章节中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Common chemistry, manufacturing, and control deficiencies in abbreviated new drug applications assessed by the US Food and drug administration: Hurdle to access cost-effective medicines

To market a generic product in the United States, it must be registered in Common Technical Document (CTD) format with the US Food and Drug Administration. The Generic Drug User Fee Act went into force in 2012, to expedite the timely review of Abbreviated New Drug Applications (ANDA) by communicating potential defects in the application to the applicant through deficiency letters at different time intervals during the review cycle. This often delays product approval since these deficiencies must be resolved before the product can be approved. In the present study, a study was performed to analyze the recurrent queries for ANDA applications in the CTD quality module from 2013 to 2020, and the probable corrective and preventive action to be taken was drafted. The most frequently occurring queries were observed in the sections titled “Description of manufacturing process and process controls”, “Controls of critical steps and intermediates”, “Specifications (Control of drug product)”, and “Stability data”.

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来源期刊
Journal of pharmacological and toxicological methods
Journal of pharmacological and toxicological methods PHARMACOLOGY & PHARMACY-TOXICOLOGY
CiteScore
3.60
自引率
10.50%
发文量
56
审稿时长
26 days
期刊介绍: Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.
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