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Analytical Method Development and Validation

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 | #643305 in Books |  CRC Press |  1997-05-18 |  1997-05-16 | Original language:English | PDF # 1 |  8.50 x.22 x5.43l,.28 | File type: PDF | 96 pages

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||2 of 2 people found the following review helpful.| Limited scope|By S. Clark|I have to admit being a bit disappointed with this book. The content is sound, based to a large extent on ICH guidance, and for the most part, applies concepts to HPLC analysis. The actual text begins on p17 and ends on p 83, with an average words/page <250 (there are likely less than 16000 words in the entire text). So my rating is biased by what I co

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...

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