Clinical Trials - Pharmaceutical Science Products

  • Biomarker Analysis in Clinical Trials with R

    1st Edition

    By Nusrat Rabbee

    Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and…

    Hardback – 2020-04-02 
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Estimands, Estimators and Sensitivity Analysis in Clinical Trials

    1st Edition

    By Craig Mallinckrodt, Geert Molenberghs, Ilya Lipkovich, Bohdana Ratitch

    The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using…

    Hardback – 2020-01-03 
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Drug-Drug Interactions

    2nd Edition

    Edited by A. David Rodrigues

    Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new…

    Paperback – 2019-12-02
    CRC Press

  • The Clinical Research Process in the Pharmaceutical Industry

    1st Edition

    Edited by Gary M. Matoren

    This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.…

    Paperback – 2019-12-02
    CRC Press

  • Innovative Statistics in Regulatory Science

    1st Edition

    By Shein-Chung Chow

    Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in…

    Hardback – 2019-11-07
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Physician Investigator Handbook

    GCP Tools and Techniques, Second Edition, 1st Edition

    By Deborah Rosenbaum, Fred Smith

    A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager,…

    Paperback – 2019-10-10
    CRC Press

  • Statistical Methods for Clinical Trials

    1st Edition

    By Mark X. Norleans

    "Summarizes graphical analysis, analysis of variance, meta-analysis, and design of comparable treatment groups. Streamlines the analytical techniques for continuous, categorical, longitudinal, and survival data-focusing on generalized linear models, GEEs, and mixed linear models, -ahd highlihgts…

    Paperback – 2019-09-23
    CRC Press

  • Adaptive and Flexible Clinical Trials

    1st Edition

    By Richard Chin

    Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in…

    Paperback – 2019-09-19
    CRC Press

  • Simulation for Designing Clinical Trials

    A Pharmacokinetic-Pharmacodynamic Modeling Perspective, 1st Edition

    Edited by Hui Kimko, Stephen B. Duffull

    Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a…

    Paperback – 2019-09-19
    CRC Press

  • Drug Products for Clinical Trials

    2nd Edition

    Edited by Donald Monkhouse, Charles F. Carney, Jim Clark, Peter Brun

    Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical…

    Paperback – 2019-09-19
    CRC Press

  • Excipient Toxicity and Safety

    1st Edition

    By Myra L. Weiner, Lois A. Kotkoskie

    This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.Examines excipients as…

    Paperback – 2019-09-19
    CRC Press

  • Computer-Aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates

    1st Edition

    By Jujjvarapu Satya Eswari, Swasti Dhagat, Manisha Yadav

    Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel…

    Hardback – 2019-09-11
    CRC Press

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