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“beate schmidt2”

Showing 1 - 12 of 12 results for “beate schmidt2”
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  • Formulation and Device Lifecycle Management of Biotherapeutics

    A Guidance for Researchers and Drug Developers

    by Beate Bittner, Johannes Schmidt ...
    Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a ... Read more

    $179.99 USD

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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

    $161.00 USD

  • Principles of Clinical Pharmacology

    Edited by Shiew-Mei Huang, Juan J.L. Lertora, Arthur J. Atkinson Jr. ...
    Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the ... Read more

    $112.49 USD

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

    by Tom Brody ...
    Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international ... Read more

    $71.99 USD

  • 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

    $113.00 USD

  • Fast Facts: Biosimilars in Hematology and Oncology

    Biologics and biosimilars - getting decisions right

    by Paul Cornes, Ali McBride ...
    Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – ... Read more

    Free

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

    by Tom Brody ...
    Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the ... Read more

    $89.99 USD

  • Detection and Quantification of Antibodies to Biopharmaceuticals

    Practical and Applied Considerations

    Edited by Michael G. Tovey ...
    The definitive book on the neutralization of recombinant biopharmaceuticalsRecombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects.The first and ... Read more

    $144.00 USD

  • 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

    $172.00 USD

  • Preclinical Safety Evaluation of Biopharmaceuticals

    A Science-Based Approach to Facilitating Clinical Trials

    Edited by Joy A. Cavagnaro ...
    "The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."—From the Afterword by Anthony D. DayanProper preclinical safety ... Read more

    $189.00 USD

  • Flow Cytometry in Drug Discovery and Development

    Edited by Virginia Litwin, Philip Marder ...
    This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The ... Read more

    $129.00 USD

  • The EBMT/EHA CAR-T Cell Handbook

    Edited by Nicolaus Kröger, John Gribben, Christian Chabannon, Ibrahim Yakoub-Agha, Hermann Einsele ...
    Series series Medicine (R0)
    This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance ... Read more

    Free