FDA化学仿制药透皮贴剂生物等效性指导原则研究与分析一朱凤昌2021.8

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FDA化学仿制药透皮贴剂生物等效性指导原则研究与分析一朱凤昌2021.8




FDA 化学仿制药透皮贴剂生物等效性指导原则研究与分析 朱凤昌1 ，江翊国2 ，郑稳生3 ，张华吉1 ，杨春宁1 ，郭双1 ，丁丽霞1* ( 1． 中国药学会，北京 100050; 2． 南京医科大学附属苏 州科技城医院，江苏 苏州 215153; 3． 中国医学科学院北京协和医学院药物研究所，北京 100050) 摘要: 目的 研究 FDA《特定药物的生物等效性指导原则》对透皮贴剂生物等效性研究的相关规定，为我国仿制药质量和疗效 一致性评价工作提供借鉴和帮助。方法 根据美国 FDA 2018 年 4 月发布的部分透皮贴剂目录，结合 FDA 特定药物的生物等 效性指导原则进行分析，从具体研究类型入手，着重对部分品种从试验设计、试验方案、受试者选择及纳入与排除标准、检测 物质、生物等效性豁免等方面进行介绍分析。结果 与常规剂型相比，FDA《特定药物的生物等效性指导原则》规定透皮贴剂 仿制药生物等效性研究，除了开展以药动学为终点的生物等效性研究外，还应遵循 FDA《ANDA: 评价经皮和局部给药系统的 黏附力( 草案) 》及《ANDA: 评价经皮和局部给药系统的刺激性和致敏可能性( 草案) 》的整体思路，开展黏附性研究、皮肤刺激 性和致敏性研究，并从多个方面进行较为详细的规范描述，对透皮贴剂仿制药的发展具有重要的推动作用。结论 在国家药 品监督管理局尚未颁布针对透皮贴剂生物等效性研究相关规定的背景下，《特定药物的生物等效性指导原则》对透皮贴剂相 关规范对我国正在进行的仿制药质量和疗效一致性评价工作具有一定指导和借鉴意义。


关键词: 透皮贴剂; 生物等效性; 指导原则; 仿制药 doi: 10. 11669 /cpj. 2021. 15. 014 中图分类号: Ｒ95 文献标志码: A 文章编号: 1001 － 2494( 2021) 15 － 1265 － 08


Investigation of FDA Issued Guidance for Bioequivalence Ｒecommendations for Specific Products Ｒelated with Transdermal Patches ZHU Feng-chang 1 ，JIANG Yi-guo 2 ，ZHENG Wen-sheng 3 ，ZHANG Hua-ji 1 ，YANG Chun-ning 1 ，GUO Shuang 1 ， DING Li-xia 1* ( 1． Chinese Pharmaceutical Association，Beijing 100050，China; 2． The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University，Suzhou 215153，China; 3． Institute of Materia Medica，Chinese Academy of Medical Sciences and Peking Union Medical College，Beijing 100050，China) ABSTＲACT: OBJECTIVE To investigate FDA issued guidance on Bioequivalence Ｒecommendations for Specific Products related to transdermal patches，which provide reference and assistance for the consistent evaluation of the quality and efficacy of generic drugs in China. METHODS According to the partial transdermal patch catalogue released by FDA in April 2018，combined with Bioequivalence Ｒecommendations for Specific Products related to transdermal patches for analysis of recommended Studies，including study designs and schemes，selection，inclusion and exclusion criteria of bioequivalence subjects，strength，selection of reference products，analytics to measure，waiver request of in vivo testing，etc. ＲESULTS Different from conventional dosage form of chemical drugs，FDA Bioequivalence Ｒecommendations for Specific Products stipulates that transdermal patch bioequivalence studies of generic drugs should be carried out，in addition to bioequivalence study with pharmacokinetic endpoints，the applicant should carry out adhesion study，skin irritation and sensitization study，respectively following FDA's current thinking in the guidance Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs，guidance Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs，which provides detailed provisions on the bioequivalence evaluation of specific generics of transdermal patch from various aspects，and plays an important role in promoting the development of generic drugs in China. CONCLUSION Studying and FDA issued analyzing Bioequivalence Ｒecommendations for Specific Products related to transdermal patches by would be conducive to understanding the bioequivalence standards and has certain guidance and reference significance to the ongoing evaluation of the quality and efficacy of generic drugs in China，since NMPA has not released similar guidance on transdermal patches． KEY WOＲDS: transdermal patch; bioequivalence; issued guidance; generic drug

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