Handbook of Bioequivalence Testing 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Niazi, Sarfaraz K. 作者

CRC Pr I Llc

译者

2007-9 出版日期

550 页数

$ 271.14 价格

HRD

丛书系列

9780849303951 图书编码

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Handbook of Bioequivalence Testing 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

Handbook of Bioequivalence Testing 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Handbook of Bioequivalence Testing 在线电子书 pdf 下载 txt下载 epub 下载 mobi 在线电子书下载

Handbook of Bioequivalence Testing 在线电子书图书描述

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies

Handbook of Bioequivalence Testing 在线电子书下载 mobi epub pdf txt 在线电子书下载

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