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  • Formulation and Device Lifecycle Management of Biotherapeutics

    A Guidance for Researchers and Drug Developers

    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 ... Leer más

    $179.99 USD

  • Audiolibro

    Abenteuer

    Die Kunst der Einfachhheit - Geschichten in Einfacher Sprache

    Completo

    3 hora 30 minutos

    Es gibt Menschen, die lesen gern Geschichten in Einfacher Sprache. Aber solche Geschichten gibt es viel zu wenig. Deshalb organisiert die Lebenshilfe Berlin regelmäßig den Literaturwettbewerb "Die Kunst der Einfachheit". Im Jahr 2024 haben 331 Autoren und Autorinnen Texte eingesendet. Das Thema war Abenteuer. 20 dieser Abenteuer warten auf Sie in diesem Buch, liebe Leserin, lieber Leser. Wussten ... Leer más

    $14.99 USD

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  • 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

  • Principles of Clinical Pharmacology

    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 ... Leer más

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  • Clinical Trials

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

    de 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 ... Leer más

    $71.99 USD

  • Pharmaceutical Toxicology in Practice

    A Guide to Non-clinical Development

    Edición de 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 ... Leer más

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  • Fast Facts: Biosimilars in Hematology and Oncology

    Biologics and biosimilars - getting decisions right

    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 – ... Leer más

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  • Clinical Trials

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

    de 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 ... Leer más

    $89.99 USD

  • Detection and Quantification of Antibodies to Biopharmaceuticals

    Practical and Applied Considerations

    Edición de 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 ... Leer más

    $144.00 USD

  • Biosimilars of Monoclonal Antibodies

    A Practical Guide to Manufacturing, Preclinical, and Clinical Development

    Edición de 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, ... Leer más

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  • Preclinical Safety Evaluation of Biopharmaceuticals

    A Science-Based Approach to Facilitating Clinical Trials

    Edición de 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 ... Leer más

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  • Flow Cytometry in Drug Discovery and Development

    Edición de 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 ... Leer más

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