1st Edition

Current Topics in Nonclinical Drug Development Volume 2

    487 Pages 39 Color & 27 B/W Illustrations
    by CRC Press

    487 Pages 39 Color & 27 B/W Illustrations
    by CRC Press

    The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.

    Select topics include:

    • Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology.
    • Current approaches to carcinogenicity testing.
    • Predicting drug-drug interactions.
    • Current understanding of idiosyncratic drug reaction.
    • Assessing cardiovascular risks beyond QT interval.
    • Use of 3D cell cultures in toxicology and ADME.
    • Development of small molecule-antibody complexes.
    • Differentiating adverse from non-adverse findings in nonclinical studies.

    Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.


    1. Introduction and History of Digital Toxicologic Pathology

    Dan Rudmann, Vanessa Schumacher, Oliver Turner, and Danielle Brown


    2. Carcinogenicity Testing of Human Pharmaceuticals

    Jan Wilhelm van der Laan; Britt Duijndam; and Bob van de Water


    3. Differentiating Adverse and Non-adverse Findings in Nonclinical Studies

    John R Foster, Vasanthi Mowat, and Chirukandath Gopinath


    4. Current Understanding of Idiosyncratic Drug Reactions

    Jack Uetrecht


    5. Three-Dimensional Cell Culture Models in Toxicology and ADME

    Alison Vickers


    6. Assessing Cardiovascular Risk Beyond the hERG Channel and the QT Interval

    Peter Hoffman & Michael K. Pugsley


    7. Fundamentals of Drug-Drug Interactions

    Hilmar Schiller, Gian Camenisch, & Felix Huth


    8. Development of Small Molecule-Antibody Complexes

    Kuno Wursch & Rebecca Watson


    Pritam S. Sahota, PhD, studied for his Veterinary Medicine (BVSc) and Veterinary Pathology (MVSc and PhD) degrees at Punjab Agricultural University in India. He is a Diplomate of the American Board of Toxicology. After completing his PhD, he immigrated to the USA in 1976 and worked for Dawson Research Corporation in Orlando, Florida for 10 years with increasing responsibilities as Toxicologic Pathologist, Senior Toxicologic Pathologist, and Scientific Director. Since 2012, Dr. Sahota has been President of Global ToxPath LLC (Toxicologic Pathology Consultancy) located in Kennewick, WA.

    Philip Bentley, PhD, is Principal Consultant at Toxicodynamix International LLC. He studied biochemistry at the University of Hull, UK, graduating with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at the Universities of Basel. Switzerland and Mainz, Germany. He has authored more than 80 scientific publications, has lectured in toxicology at the University of Basel for more than 30 years, and is a past President of the European Society of Biochemical Pharmacology and the Swiss Society of Toxicology.

    Zbigniew W. Wojcinski, DVM, DVSc is President of Toxicology & Pathology Consulting, LLC, in Hillsborough, NC and has over 35 years’ experience in pharmaceutical drug development. Dr. Wojcinski earned his undergraduate degree (BSc) in Zoology from the University of Toronto and his DVM and DVSc (Pathology) degrees from the Ontario Veterinary College, University of Guelph. He is a certified Diplomate of the American Board of Toxicology and a Diplomate of the American College of Veterinary Pathologists.