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Handbook of analytical validation

  1. Údaje o názvuHandbook of analytical validation / Michael E. Swartz
    Osobní jméno Swartz, Michael (Michael E.), 1958- (autor)
    NakladatelHoboken : CRC Press, 2012
    Fyz.popis1 online zdroj (218 stran)
    ISBN9781420014488 (online ; pdf)
    142001448X
    Poznámky k dostupnostiPřístup pouze pro oprávněné uživatele
    PoznámkyZpůsob přístupu: World Wide Web
    DefektyeBooks on EBSCOhost
    Předmět.hesla testování léků drugs testing * chromatografická analýza chromatographic analysis * farmaceutická chemie pharmaceutical chemistry
    Forma, žánr elektronické knihy electronic books
    Konspekt615 - 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
    URLhttp://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=452076
    kniha

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    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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