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 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
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
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
Specification of Drug Substances and Products
Language: en
Pages: 696
Authors: Christopher M. Riley
Categories: Science
Type: BOOK - Published: 2020-07-23 - Publisher: Elsevier

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis