Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Cyndy E. Lumley 作者

Springer

譯者

1998-06-30 出版日期

218 頁數

USD 169.00 價格

Hardcover

叢書系列

9780792387329 圖書編碼

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發表於2024-09-24

Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書 epub 下載 mobi 下載 pdf 下載 txt 下載 2024

Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書 epub 下載 pdf 下載 mobi 下載 txt 下載 2024

Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書 pdf 下載 txt下載 epub 下載 mobi 下載 2024

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Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書 pdf 下載 txt下載 epub 下載 mobi 在線電子書下載

Safety Evaluation of Biotechnologically-Derived Pharmaceuticals 在線電子書圖書描述

Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline 'Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.

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