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Handbook of Analytical Validation
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Handbook of Analytical Validation

Book Details

Format Hardback or Cased Book
ISBN-10 0824706897
ISBN-13 9780824706890
Publisher Taylor & Francis Inc
Imprint CRC Press Inc
Country of Manufacture GB
Country of Publication GB
Publication Date Apr 24th, 2012
Print length 220 Pages
Weight 514 grams
Dimensions 24.10 x 16.10 x 1.80 cms
Ksh 34,200.00
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Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation.

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.


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