Drug Design & Development Products

  • Biosimilar Drug Product Development

    Edited by Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow

    When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The…

    Hardback – 2017-03-09 
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Toxicologic Pathology

    Nonclinical Safety Assessment

    Edited by Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath

    As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical…

    Paperback – 2017-02-28 
    CRC Press

  • Methods in Comparative Effectiveness Research

    Edited by Constantine Gatsonis, Sally C. Morton

    Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that…

    Hardback – 2017-02-10 
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

    By Harry Yang

    The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and…

    Hardback – 2016-12-01
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Handbook of Metallonutraceuticals

    Edited by Yashwant Vishnupant Pathak, Jayant N. Lokhande

    The nutritional and medicinal value of metals, such as zinc, calcium, and iron, has been known in traditional medicine for a long time. Other metals, such as silver and gold, may also have therapeutic and health benefits. Ancient medicines have long incorporated their use in the treatment of…

    Paperback – 2016-11-16
    CRC Press
    Nutraceuticals

  • Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition

    Edited by Linda A. Felton

    Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many…

    Hardback – 2016-10-13
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Handbook for Chemical Process Research and Development

    By Wenyi Zhao

    The Handbook for Chemical Process Research and Development focuses on developing processes for chemical and pharmaceutical industries. Forty years ago there were few process research and development activities in the pharmaceutical industry, partially due to the simplicity of the drug molecules.…

    Hardback – 2016-09-27
    CRC Press

  • Biocalorimetry

    Foundations and Contemporary Approaches

    Edited by Margarida Bastos

    Connecting past, present, and future instrument development and use, Biocalorimetry: Foundations and Contemporary Approaches explores biocalorimetry’s history, fundamentals, methodologies, and applications. Some of the most prominent calorimeter developers and users share invaluable personal…

    Hardback – 2016-05-09
    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 – 2016-03-03
    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

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