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Handbook of analytical validation
Údaje o názvu Handbook of analytical validation / Michael E. Swartz Osobní jméno Swartz, Michael (Michael E.), 1958- (autor) Nakladatel Hoboken : CRC Press, 2012 Fyz.popis 1 online zdroj (218 stran) ISBN 9781420014488 (online ; pdf) 142001448X Úplný obsah Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation. Poznámky k dostupnosti Přístup pouze pro oprávněné uživatele Poznámky Způsob přístupu: World Wide Web Defekty eBooks on EBSCOhost Předmět.hesla testování léků drugs testing * chromatografická analýza chromatographic analysis * farmaceutická chemie pharmaceutical chemistry Forma, žánr elektronické knihy electronic books Konspekt 615 - Farmacie. Farmakologie MDT 615.038 , 615:54 , 543.54 , (0.034.2:08) Země vyd. Spojené státy americké Jazyk dok. angličtina Druh dok. Elektronické zdroje URL http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=452076 kniha
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types.
Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation.
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