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