Research and Education Needs for Complex Generics.
Research and Education Needs for Complex Generics.
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DOI：
10.1007/s11095-021-03149-y
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发表时间：
2021-12
影响因子：
3.7
通讯作者：
Polli JE
中科院分区：
文献类型：
--
作者：
Stern S;Coghlan J;Krishnan V;Raney SG;Babiskin A;Jiang W;Lionberger R;Xu X;Schwendeman A;Polli JE
复杂仿制药是药品的仿制版本，通常具有复杂的活性成分、复杂的配方、复杂的给药途径、复杂的剂型，是复杂的药物器械组合产品，或者具有其他特征，使得证明生物等效性或开发为仿制药变得复杂。这些复杂产品（即复杂仿制药）是美国的重要组成部分。美国食品药品监督管理局（FDA）仿制药用户费用修订（GDUFA） II承诺函。复杂仿制药研究中心（CRCG）是由FDA拨款成立的，旨在解决与复杂仿制药开发相关的挑战。为了了解这些挑战，CRCG进行了一项“复杂仿制药开发中的科学挑战调查”。问题的三个主要领域是针对哪种（类型）复杂产品，哪种分析方法来支持生物等效性的演示，以及CRCG应该优先考虑哪些教育主题。该调查在CRCG维护的网站上向公众开放。对于复杂产品，前三名的选择是复杂注射剂、配方和纳米材料；药物器械组合产品；还有吸入和鼻用产品。在分析方法方面，前三名的选择是基于局部作用生理的药代动力学建模；口服吸收模型和生物等效性；数据分析和机器学习。在教育主题方面，前三名的选择是复杂注射剂、配方和纳米材料；药物器械组合产品；以及数据分析，包括定量方法和建模与仿真。这些调查结果将有助于优先考虑CRCG的初步研究和教育活动。在线版本包含补充材料，可在10.1007/s11095-021-03149-y获得。
Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e. complex generics) are an important element of the United States (U.S.) Food and Drug Administration’s (FDA’s) Generic Drug User Fee Amendments (GDUFA) II Commitment Letter. The Center for Research on Complex Generics (CRCG) was formed by a grant from the FDA to address challenges associated with the development of complex generics. To understand these challenges, the CRCG conducted a “Survey of Scientific Challenges in the Development of Complex Generics”. The three main areas of questioning were directed toward which (types of) complex products, which methods of analysis to support a demonstration of bioequivalence, and which educational topics the CRCG should prioritize. The survey was open to the public on a website maintained by the CRCG. Regarding complex products, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and inhalation and nasal products. Regarding methods of analysis, the top three selections were locally-acting physiologically-based pharmacokinetic modeling; oral absorption models and bioequivalence; and data analytics and machine learning. Regarding educational topics, the top three selections were complex injectables, formulations, and nanomaterials; drug-device combination products; and data analytics, including quantitative methods and modeling & simulation. These survey results will help prioritize the CRCG’s initial research and educational initiatives. The online version contains supplementary material available at 10.1007/s11095-021-03149-y.
影响因子：
5.4
作者：
Gudicha DW;Schmittmann VD;Vermunt JK
通讯作者：
Vermunt JK