Specification Of Drug Substances And Products Development And Validation Of Analytical Methods  at Meripustak

Specification Of Drug Substances And Products Development And Validation Of Analytical Methods

Books from same Author: Unknown AEHLERT

Books from same Publisher: ELSEVIER

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  • General Information  
    Author(s)Unknown AEHLERT
    PublisherELSEVIER
    Edition2nd Edition
    ISBN9780080983509
    Pages390
    BindingHardbound
    LanguageEnglish
    Publish YearOctober 2013

    Description

    ELSEVIER Specification Of Drug Substances And Products Development And Validation Of Analytical Methods by Unknown AEHLERT

    Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.