Generic Drug Product Development 2024 pdf epub mobi 电子书 图书描述 The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the...
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In: Generic Drug Product Development: Bioequivalence Issues. Drugs and the Pharmaceutical Science. Edited by Kanfer I, Shargel L. CRC Press, Taylor & Francis Group, USA 2007, 180: 1 - 14.Verbeeck RK, Warlin J. The European Union, in Kanfer I, Shargel L (eds), Generic Drug Product ...
作者:Shargel, Leon 出版年:2004-12 页数:408 定价:$ 203.34 ISBN:9780824754600 豆瓣评分 目前无人评价 评价: 写笔记 写书评 加入购书单 分享到 内容简介· ··· Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from pro...
Generic Drug Product Development: Specialty Dosage Forms explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. In addition, the book provides various scientific approaches and regulatory requirements for manufacturers to demonstrate the therapeutic...
Finally, the future of generic drug product development and considerations to improve their regulation were discussed. More efforts will continue to enable a more efficient and rational generic drug product development and shortening of the review period for partial change approval. 展开 ...
Generic Drug Product Development: Bioequivalence Issues The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to th... I Kanfer,...
Generic drugs do not need to contain the same inactive ingredients as the brand name product.However, a generic drug can only be marketed after the brand name drug's patent has expired, which may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food ...
Furthermore, the key players are focusing on the development of specialty generics and strategies like first-to-file and first-to-market in order to make additional profits and strengthen their position in the market. In 2022, around 106 drugs received their first-time generic drug approvals in...