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Handbook of Analytical Validation.

Handbook of Analytical Validation.

・ISBN 978-0-8247-0689-0 hard GB£ 210.00

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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 9780429132339
著者・編者Swartz, Michael E. / Krull, Ira S.,
出版社 (CRC Press Inc, US)
出版年月2012
ページ数220 pp.
言語ENG
ニュース番号<A00-23809>

解説

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:

  • Contains practical, up-to-date guidelines for analytical method validation
  • Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications
  • Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment

Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.