Drug Discovery and Development, Third Edition

Acknowledgments

Introduction to the First Edition (1992)

Introduction to the Second Edition (2006)

Editors

Contributors

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

Index

Biography

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