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    Validation of Analytical Methods for Pharmaceutical Analysis

Validation of Analytical Methods for Pharmaceutical Analysis

Oona McPolin

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      Format:

      This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
      CONTRIBUTORS: Oona McPolin EAN: 9780956152817 COUNTRY: United Kingdom PAGES: WEIGHT: 382 g HEIGHT: 297 cm
      PUBLISHED BY: Mourne Training Services DATE PUBLISHED: 2009-05-19 CITY: GENRE: MEDICAL / Pharmacy, SCIENCE / General WIDTH: 210 cm SPINE:

      Book Themes:

      Science: general issues

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      Format:

      This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
      CONTRIBUTORS: Oona McPolin EAN: 9780956152817 COUNTRY: United Kingdom PAGES: WEIGHT: 382 g HEIGHT: 297 cm
      PUBLISHED BY: Mourne Training Services DATE PUBLISHED: 2009-05-19 CITY: GENRE: MEDICAL / Pharmacy, SCIENCE / General WIDTH: 210 cm SPINE:

      Book Themes:

      Science: general issues

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      Be the first to write a review
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