Drug Design & Development Products

  • Biocalorimetry

    Foundations and Contemporary Approaches

    Edited by Margarida Bastos

    This book provides a current and comprehensive overview of state-of-the-art approaches in biocalorimetry. Starting with a brief historical introduction to calorimetry, the book goes on to discuss prospects for calorimeter development in the near future. Thereafter, a number of unique up-to-date…

    Hardback – 2016-05-11 
    CRC Press

  • Pharmaceutical Product Development

    Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

    Edited by Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee

    Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the…

    Hardback – 2016-03-14 
    CRC Press

  • Applying Pharmacogenomics in Therapeutics

    Edited by Xiaodong Feng, Hong-Guang Xie

    Recent advances in high-throughput gene sequencing and other omics biotechnologies have served as a springboard for the field of pharmacogenomics. Pharmacogenomics is now generally accepted as the major determinant of variable drug safety, efficacy, and cost-effectiveness. Therefore, widespread use…

    Hardback – 2016-01-27
    CRC Press

  • Biosimilar and Interchangeable Biologics

    From Cell Line to Commercial Launch, Two Volume Set

    By Sarfaraz K. Niazi

    What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time…

    Hardback – 2015-12-23
    CRC Press

  • Biosimilars and Interchangeable Biologics

    Strategic Elements

    By Sarfaraz K. Niazi

    What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time…

    Hardback – 2015-12-23
    CRC Press

  • Biosimilars and Interchangeable Biologics

    Tactical Elements

    By Sarfaraz K. Niazi

    What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time…

    Hardback – 2015-12-23
    CRC Press

  • Developability of Biotherapeutics

    Computational Approaches

    Edited by Sandeep Kumar, Satish Kumar Singh

    Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches…

    Hardback – 2015-12-14
    CRC Press

  • Fundamental Concepts for New Clinical Trialists

    By Scott Evans, Naitee Ting

    Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book…

    Hardback – 2015-09-25
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Statistical Methods for Drug Safety

    By Robert D. Gibbons, Anup Amatya

    Explore Important Tools for High-Quality Work in Pharmaceutical Safety Statistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of…

    Hardback – 2015-07-21
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Exposure–Response Modeling

    Methods and Practical Implementation

    By Jixian Wang

    Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response…

    Hardback – 2015-07-17
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Topical Antimicrobials Testing and Evaluation, Second Edition

    By Daryl S. Paulson

    A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to…

    Hardback – 2014-12-20
    CRC Press

  • Quantitative Evaluation of Safety in Drug Development

    Design, Analysis and Reporting

    Edited by Qi Jiang, H. Amy Xia

    State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and…

    Hardback – 2014-12-08
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

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