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Handbook of Analytical Validation by Michael E. Swartz, Ira S. Krull

Handbook of Analytical Validation

by Michael E. Swartz , Ira S. Krull
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Book cover type: Hardcover
  • ISBN13: 9781498715072
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: CRC Press
  • Publisher Imprint: CRC Press
  • Publication Date:
  • Pages: 226
  • Original Price: GBP 115.0
  • Language: English
  • Edition: N/A
  • Item Weight: 495 grams
  • BISAC Subject(s): Chemistry / Analytic

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, it contains practical, up-to-date guidelines for analytical method validation. It also 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 the biotech industry.

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