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ICH QUALITY GUIDELINES

AN IMPLEMENTATION GUIDE


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Sinopse

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. •    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies •    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines •    Uses case studies to help readers understand and apply ICH guidelines •    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines •    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Detalhes do Produto

    • Edição:  1
    • Ano de Edição: 2017
    • Ano:  2017
    • País de Produção: Canada
    • Código de Barras:  2001117647292
    • ISBN:  9781118971130

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