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Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing.

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing.

・ISBN 978-0-367-73664-4 paper GB£ 54.99

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お気に入り
電子版あり 大学・学術機関向け電子ブック(eBook)ISBN 978-1-315-37172-6
著者・編者Yang, Harry,
シリーズChapman & Hall/CRC Biostatistics Series
出版社(Chapman & Hall/CRC, UK)
出版年月2020
ページ数386 pp.
言語ENG
ニュース番号<M25-837>

解説

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.