Handbook of Bioequivalence Testing 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Niazi, Sarfaraz K. 作者

CRC Pr I Llc

譯者

2007-9 出版日期

550 頁數

$ 271.14 價格

HRD

叢書系列

9780849303951 圖書編碼

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發表於2024-07-03

Handbook of Bioequivalence Testing 在線電子書 epub 下載 mobi 下載 pdf 下載 txt 下載 2024

Handbook of Bioequivalence Testing 在線電子書 epub 下載 pdf 下載 mobi 下載 txt 下載 2024

Handbook of Bioequivalence Testing 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Handbook of Bioequivalence Testing 在線電子書 pdf 下載 txt下載 epub 下載 mobi 在線電子書下載

Handbook of Bioequivalence Testing 在線電子書圖書描述

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 在線電子書下載 mobi epub pdf txt 在線電子書下載

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