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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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. Analyst ...a useful primer-type book covering validation of analytical methods. ...recommended.
Preface3Tables and Figures11Abbreviations131Introduction172Method Development, Optimization, and Validation Approaches253Method Validation (USP/ICH)534System Suitability735Method Validation Protocol756Method Transfer and Revalidation817Summary and Conclusions83Bibliography85
\ Analyst...a useful primer-type book covering validation of analytical methods. ...recommended.\ \ \ \ \ INFORMStop and read this...book to understand a formal way to develop or to improve and validate your methods.... In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions.\ \ \ Analyst...a useful primer-type book covering validation of analytical methods. ...recommended.\ \ \ \ \ INFORMStop and read this...book to understand a formal way to develop or to improve and validate your methods.... In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions\ \
