Handbook of Analytical Validation

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9780824706890: Handbook of Analytical Validation
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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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    About the Author:

    Northeastern University, Boston, Massachusetts, USA Synomics Pharmaceuticals Svcs LLC, Massachusetts, USA

    Review:

    "The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."
    ―www.chemistryworld.org 1 November 2012 1 Chemistry World 163

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    Book Description Taylor Francis Inc, United States, 2012. Hardback. Condition: New. Language: English . Brand New Book. 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. Seller Inventory # AA69780824706890

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