3rd Edition

Drug Discovery and Development, Third Edition

    696 Pages 21 Color & 77 B/W Illustrations
    by CRC Press

    696 Pages 21 Color & 77 B/W Illustrations
    by CRC Press

    696 Pages 21 Color & 77 B/W Illustrations
    by CRC Press

    Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided.


    • Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries

    • Case study detailing the discovery of the anti-cancer drug, lorlatinib

    • Venture capitalist commentary on trends and best practices in drug discovery and development

    • Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding

    • Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research

    • Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business



    Introduction to the First Edition (1992)

    Introduction to the Second Edition (2006)



    Chapter 1: Introduction to Drug Discovery and Development

    James J. O’Donnell III, John C. Somberg, and James T. O’Donnell

    SECTION I Overview

    Chapter 2: Current Opinions on the Trajectory of the Pharmaceutical Development

    John C. Somberg

    Chapter 3: Innovation in Drug Development: Perspectives of a Venture Capitalist

    Krishna Yeshwant

    SECTION II Drug Discovery

    Chapter 4: High-Throughput Screening

    Olivia Perez, J. Pena, Virneliz Fernandez-Vega, Louis Scampavia, and Timothy Spicer

    Chapter 5: DNA-Encoded Compound Libraries: An Emerging Paradigm in Drug Hit Discovery

    Raphael M. Franzini

    Chapter 6: Bio-Targeted Nanomaterials for Theranostic Applications

    Sabyasachi Maiti and Kalyan Kumar Sen

    Chapter 7: The Development of Adoptive T-Cell Immunotherapies for Cancer: Challenges and Prospects

    David J. Dow, Steven J. Howe, Mala K. Talekar, and Laura A. Johnson

    Chapter 8: CRISPR in Drug Discovery

    Chih-Shia Lee and Ji Luo

    Chapter 9: Probiotics in the World: “Bugs-as-Drugs”

    Thomas Kuntz, Madeline Kim, Elle Simone Hill, Mariana C. Salas Garcia, and Jack A. Gilbert

    Chapter 10: Discovery and Early Development of the Next-Generation ALK Inhibitor, Lorlatinib (18): Agent for Non·Small-Cell Lung Cancer

    Paul F. Richardson

    SECTION III Drug Development

    Chapter 11: Integrated Drug Product Development: From Lead Candidate Selection to Life-Cycle Management

    Madhu Pudipeddi, Abu T.M. Serajuddin, Ankita V. Shah, and Daniel Mufson

    Chapter 12: New Trends in Pharmacological and Pharmaceutical Profiling

    Lyn Rosenbrier Ribeiro, Duncan Armstrong, Thierry Jean, and Jean-Pierre Valentin

    Chapter 13: Pharmacokinetics·Pharmacodynamics in New Drug Development

    Sarfaraz K. Niazi

    Chapter 14: The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms

    Jibin Li and Ismael J. Hidalgo

    Chapter 15: Preclinical Toxicology

    Damani Parran

    Chapter 16: Safety Pharmacology: Past, Present, and Future

    Jean-Pierre Valentin, Annie Delaunois, Marie-Luce Rosseels, Vitalina Gryshkova, and Tim G. Hammond

    Chapter 17: Ethical Concerns in Clinical Research

    Jonathan C. Young and Lori Nesbitt

    Chapter 18: Clinical Trials Methodology

    John Somberg

    Chapter 19: The Academic Research Enterprise

    Crista Brawley, Mary Jane Welch, Jeff Oswald, Erin Kampschmidt, Jennifer Garcia, Allecia Harley, Shrijay Vijayan, John McClatchy, Stephanie Guzik, and Stephanie Tedford

    Chapter 20: Clinical Testing Challenges in HIV/AIDS Research

    Vincent Idemyor

    Chapter 21: The Evolving Role of the Pharmacist in Clinical, Academic, and Industry Sectors

    Gourang Patel and Stephanie Tedford

    Chapter 22: Intellectual Property in the Drug Discovery Process

    Martha M. Rumore and William Schmidt

    Chapter 23: Drug Repurposing: Academic Clinician Research Endeavors

    Kathleen Heneghan and Stephanie E. Tedford

    SECTION IV Regulations

    Chapter 24: The Role of the Regulatory Affairs Professional in Guiding New Drug Research, Development, and Approval

    S. Albert Edwards

    Chapter 25: Orphan Drug Development and Regulations

    A.M. Lynch

    Chapter 26: Development of Drug Products for Older Adults: Challenges, Solutions, and Regulatory Considerations

    S.W. Johnny Lau, Darrell R. Abernethy, and Chandrahas Sahajwalla

    Chapter 27: Clinical Pharmacology and Regulatory Concerns for Developing Drug Products for Pediatric Patients

    Janelle M. Burnham and Gilbert J. Burckart

    Chapter 28: Pharmacy Compounding Regulations

    Loyd V. Allen, Jr. and Willis C. Triplett



    James J. O'Donnell, James T. O'Donnell