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Analytical Method Development and Validation

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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2 comments:

  1. It is nice book for method validation and new method development

    Dr. vishnu

    ReplyDelete
  2. It is nice book for new method development and validation

    ReplyDelete