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Showing 1 - 12 of 12 results for “narendra chirmule”
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  • Approved: The Life Cycle of Drug Development

    Edited by Narendra Chirmule, Vihang Vivek Ghalsasi ...
    Series series Biomedical and Life Sciences (R0)
    Drug development stands at a transformative threshold in modern medicine. Over the past three decades, biotherapeutics have redefined medical innovation, paving the way for treatments that are not only effective but also accessible. This book provides a comprehensive exploration of the intricate world of drug development, shedding light on the essential balance between efficiency, regulatory ... Read more

    $280.99 CAD

  • Audiobook

    Good Genes Gone Bad

    A Short History of Vaccines and Biologics: Failures, Successes, Controversies

    by Narendra Chirmule ...
    Narrated by Mishal Varma ...

    Unabridged

    6 hours 32 min

    The field of biotechnology has evolved over the past four decades, developing medicines which are curing diseases. But this journey of success has been tough and arduous, built upon the shoulders of major failures. Good Genes Gone Bad highlights seven such colossal failures in drug development-all of which culminated in the development of novel drugs-weaving together various analogies through the ... Read more

    $23.99 CAD

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  • Early Drug Development

    Strategies and Routes to First-in-Human Trials

    Edited by 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 ... Read more

    $215.99 CAD

  • Pharmaceutical Toxicology in Practice

    A Guide to Non-clinical Development

    Edited by Alberto Lodola, Jeanne Stadler ...
    This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical ... Read more

    $145.99 CAD

  • Basic Principles of Drug Discovery and Development

    by Benjamin E. Blass ...
    Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, providing comprehensive explanations of enabling technologies such as high throughput screening, structure based drug design, molecular modeling, pharmaceutical profiling, and translational medicine, all areas that have become critical steps in the successful ... Read more

    $66.99 CAD

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    by 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 ... Read more

    $217.99 CAD

  • Value Creation in the Pharmaceutical Industry

    The Critical Path to Innovation

    by Alexander Schuhmacher, Markus Hinder, Oliver Gassmann ...
    This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation.A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as ... Read more

    $136.99 CAD

  • Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

    by Ralf Huss, Christine Guenther, Andrea Josefine Hauser ...
    This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and ... Read more

    $76.99 CAD

  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    by 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 ... Read more

    $204.99 CAD

  • Biosimilars of Monoclonal Antibodies

    A Practical Guide to Manufacturing, Preclinical, and Clinical Development

    Edited by Cheng Liu, K. John Morrow Jr. ...
    Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.• Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs• Features flow charts, tables, ... Read more

    $231.99 CAD

  • Navigating the FDA Regulatory Processes

    An Integrated Clinical and Engineering Approach

    Edited by Yitzhak Rosen, Pablo Gurman, Noel Elman ...
    This book provides a unique knowledge source of the FDA’s regulatory processes to anyone interested in the development and approval of biomedical products.Navigating the FDA Regulatory Processes will be of particular importance for those innovating in biomedical devices, pharmacological therapies, and combination products, who are interested in considering regulatory affairs early on in product ... Read more

    $247.99 CAD

  • A Practical Guide to Drug Development in Academia

    The SPARK Approach

    Edited by Daria Mochly-Rosen, Kevin Grimes ...
    Series series Medicine (R0)
    "A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical BiologyWritten by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic ... Read more

    $89.69 CAD