Clinical Trials - Pharmaceutical Science Products

  • 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 – 2019-11-14
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Elementary Bayesian Biostatistics

    1st Edition

    By Lemuel A. Moyé

    Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power. Presenting an introductory perspective to modern Bayesian…

    Paperback – 2019-10-18
    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 Methodology in the Pharmaceutical Sciences

    1st Edition

    By D. A. Berry

    A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate…

    Paperback – 2019-10-07
    CRC Press
    Statistics: A Series of Textbooks and Monographs

  • 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

  • Outsourcing in Clinical Drug Development

    1st Edition

    Edited by Roy Drucker, Graham Hughes

    Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical…

    Paperback – 2019-09-11
    CRC Press

  • Development of Biopharmaceutical Parenteral Dosage Forms

    1st Edition

    Edited by Cosimo Prantera, Burton I. Korelitz

    This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose,…

    Paperback – 2019-09-05
    CRC Press

Product Search