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1 - 12 de 12 resultados para “ming q lu”
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  • Approaching China's Pharmaceutical Market

    A Fundamental Guide to Clinical Drug Development

    Edición de Ming Q. Lu ...
    Series series Biomedical and Life Sciences (R0)
    This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western ... Leer más

    $143.99 USD

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  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    de John Geigert ...
    This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published ... Leer más

    $170.99 USD

  • Sterile Product Development

    Formulation, Process, Quality and Regulatory Considerations

    Edición de Parag Kolhe, Mrinal Shah, Nitin Rathore ...
    Series series Biomedical and Life Sciences (R0)
    This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:• Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated ... Leer más

    $323.99 USD

  • Regulated Bioanalysis: Fundamentals and Practice

    Edición de Mario L. Rocci Jr., Stephen Lowes ...
    Series series Biomedical and Life Sciences (R0)
    The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated ... Leer más

    $125.99 USD

  • The Anticipation of Converging Industries

    A Concept Applied to Nutraceuticals and Functional Foods

    de Clive-Steven Curran ...
    Series series Engineering (R0)
    The blurring of boundaries between hitherto distinct scientific disciplines, technologies or markets is a common and powerful phenomenon. Subjects of this convergence often change consumer behaviours, favouring products and platforms with multiple functions. The Anticipation of Converging Industries provides a detailed focus on the triggers, drivers and consequences of convergence to create a more ... Leer más

    $143.99 USD

  • Progress in the Chemistry of Organic Natural Products 105

    Edición de A. Douglas Kinghorn, Heinz Falk, Simon Gibbons, Jun'ichi Kobayashi ...
    Series series Chemistry and Material Science (R0)
    The first contribution reviews the occurrence of xanthine alkaloids in the plant kingdom and the elucidation of the caffeine biosynthesis pathway, providing details of the N-methyltransferases, belonging to the motif B' methyltransferase family which catalyze three steps in the four step pathway leading from xanthosine to caffeine. The second contribution in this book provides a background on the ... Leer más

    $170.99 USD

  • Family Business and Technological Innovation

    Empirical Insights from the Italian Pharmaceutical Industry

    de Alessandra Perri, Enzo Peruffo ...
    Series series Business and Management (R0)
    This book explores technological innovation in family firms, seeking to reconstruct the links between the heterogeneous dimensions of family businesses and their innovative behaviour. Building on and examining the traditional view of family firms as conservative, this book contributes to knowledge surrounding the puzzling role of family firms in technological innovation, with particular focus on ... Leer más

    $49.99 USD

  • FDA Bioequivalence Standards

    Edición de Lawrence X. Yu, Bing V. Li ...
    Series series Biomedical and Life Sciences (R0)
    This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, ... Leer más

    $215.99 USD

  • Pharmacokinetics in Drug Development

    Advances and Applications, Volume 3

    Edición de Peter L. Bonate, Danny R. Howard ...
    Series series Biomedical and Life Sciences (R0)
    The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor ... Leer más

    $188.99 USD

  • Drug Delivery to the Brain

    Physiological Concepts, Methodologies and Approaches

    Edición de Margareta Hammarlund-Udenaes, Robert G. Thorne, Elizabeth C.M. de Lange ...
    Series series Biomedical and Life Sciences (R0)
    The development of new CNS drugs is notoriously difficult. Drugs must reach CNS target sites for action and these sites are protected by a number of barriers, the most important being the blood –brain barrier (BBB). Many factors are therefore critical to consider for CNS drug delivery, e.g. active/passive transport across the BBB, intra-brain distribution, and central/systemic pharmacokinetics, to ... Leer más

    $170.99 USD

  • Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

    Edición de Terrence P. Tougas, Svetlana A. Lyapustina, Jolyon P. Mitchell ...
    Series series Biomedical and Life Sciences (R0)
    The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to ... Leer más

    $143.99 USD

  • Commercial Plant-Produced Recombinant Protein Products

    Case Studies

    Edición de John A. Howard, Elizabeth E. Hood ...
    Series series Biomedical and Life Sciences (R0)
    Attention has recently turned to using plants as hosts for the production of commercially important proteins. The twelve case studies in this volume present successful strategies for using plants to produce industrial and pharmaceutical proteins and vaccine antigens. They examine in detail projects that have commercial potential or products that have already been commercialized, illustrating the ... Leer más

    $89.99 USD