LIBROS DEL AUTOR: john geigert

3 resultados para LIBROS DEL AUTOR: john geigert

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  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
    John Geigert
    Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of Amer...
    Disponible

    46,31 €

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
    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...
    Disponible

    234,81 €

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
    John Geigert
    'The greater our knowledge increases, the more our ignorance unfolds. ' U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was...
    Disponible

    268,75 €