Generic Drug Product Development 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Shargel, Leon/ Kanfer, Isadore 作者

Marcel Dekker Inc

译者

2007-11 出版日期

288 页数

$ 203.34 价格

HRD

丛书系列

9780849377846 图书编码

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发表于2024-09-16

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Generic Drug Product Development 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

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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 brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies.By exploring scientific, legal, and international regulatory challenges, "Generic Drug Development", discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

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