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1 - 12 de 12 resultados para “john geigert”
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  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    de John Geigert ...
    Series series Biomedical and Life Sciences (R0)
    CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls ... Leer más

    $179.99 USD

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    de John Geigert ...
    Series series Biomedical and Life Sciences (R0)
    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 America (USA) and ... Leer más

    $161.99 USD

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    de John Geigert ...
    Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and ... Leer más

    $152.99 USD

  • 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

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  • 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

  • The Personalized Medicine Revolution

    How Diagnosing and Treating Disease Are About to Change Forever

    de Pieter Cullis ...
    Every one of us is unique. With recent advances in technology, we now know that that statement is more true that ever: we are each individuals, right down to a molecular level - a one-of-a-kind combination of genes, proteins, and metabolism. So why does healthcare still take a one-size-fits-all approach? The same methods are used on everyone to diagnose illness, and the same drugs are used to ... Leer más

    $13.99 USD o gratis con Kobo Plus

  • Real World Drug Discovery

    A Chemist's Guide to Biotech and Pharmaceutical Research

    de Robert M. Rydzewski ...
    Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, ... Leer más

    $80.99 USD

  • Early Drug Development

    Strategies and Routes to First-in-Human Trials

    Edición de Mitchell N. Cayen ...
    The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their ... Leer más

    $161.00 USD

  • An Introduction to Genetic Engineering

    de Desmond S. T. Nicholl ...
    In this third edition of his popular undergraduate-level textbook, Des Nicholl recognises that a sound grasp of basic principles is vital in any introduction to genetic engineering. Therefore, the book retains its focus on the fundamental principles used in gene manipulation. It is divided into three sections: Part I provides an introduction to the relevant basic molecular biology; Part II, the ... Leer más

    $45.99 USD

  • Pharmaceutical Biotechnology

    Drug Discovery and Clinical Applications

    Edición de Oliver Kayser, Heribert Warzecha ...
    This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, ... Leer más

    $258.00 USD

  • Pharmaceutical Biotechnology

    Concepts and Applications

    de Gary Walsh ...
    Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject ... Leer más

    $81.00 USD

  • Human Stem Cell Manual

    A Laboratory Guide

    Edición de Jeanne F. Loring, Suzanne Peterson ...
    This manual is a comprehensive compilation of "methods that work" for deriving, characterizing, and differentiating hPSCs, written by the researchers who developed and tested the methods and use them every day in their laboratories. The manual is much more than a collection of recipes; it is intended to spark the interest of scientists in areas of stem cell biology that they may not have ... Leer más

    $89.99 USD