Analytical Method Development and Validation

Analytical Method Development and Validation
Author: Michael E. Swartz
Publisher: CRC Press
Total Pages: 95
Release: 2018-10-03
Genre: Science
ISBN: 1482229773


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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.


Analytical Method Development and Validation
Language: en
Pages: 95
Authors: Michael E. Swartz
Categories: Science
Type: BOOK - Published: 2018-10-03 - Publisher: CRC Press

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performanc
Development and Validation of Analytical Methods
Language: en
Pages: 363
Authors: Christopher M. Riley
Categories: Science
Type: BOOK - Published: 1996-05-29 - Publisher: Elsevier

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The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel
Analytical Method Validation and Instrument Performance Verification
Language: en
Pages: 320
Authors: Chung Chow Chan
Categories: Science
Type: BOOK - Published: 2004-04-23 - Publisher: John Wiley & Sons

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Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of
Method Validation in Pharmaceutical Analysis
Language: en
Pages: 418
Authors: Joachim Ermer
Categories: Science
Type: BOOK - Published: 2006-03-06 - Publisher: John Wiley & Sons

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Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calcu
Handbook of Analytical Validation
Language: en
Pages: 218
Authors: Michael E. Swartz
Categories: Medical
Type: BOOK - Published: 2012-04-24 - Publisher: CRC Press

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Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and p