Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
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DOI：
10.1208/s12248-012-9411-0
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发表时间：
2013-01-01
期刊：
影响因子：
4.5
通讯作者：
Yu, Lawrence
中科院分区：
文献类型：
--
作者：
Chang, Rong-Kun;Raw, Andre;Yu, Lawrence
这篇综述提出了在开发半固体局部仿制药时可以考虑的因素。这包括讨论在开发过程中通过设计概念实现质量，以确保仿制药具有与参考药物（RLD）相似的预期质量属性，并确保商业生产过程中的批间一致性。这包括逆向工程的概念，以复制RLD作为产品开发期间的策略，以确保定性（Q1）和定量（Q2）配方相似性以及配方微观结构（Q3）的相似性。讨论了利用体外皮肤渗透研究作为证明试验仿制药和RLD之间处方差异的工具的概念，以确保成功进行药效学或临床终点生物等效性研究。综述最后讨论了药物产品评价和质量检测以及体内生物等效性研究。
This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3). The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies.