Drug Discovery and Development, Third Edition

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.Features: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 librariesCase study detailing the discovery of the anti-cancer drug, lorlatinibVenture capitalist commentary on trends and best practices in drug discovery and developmentComprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compoundingMultidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in ResearchContributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

AcknowledgmentsIntroduction to the First Edition (1992)Introduction to the Second Edition (2006)EditorsContributorsChapter 1: Introduction to Drug Discovery and DevelopmentJames J. ODonnell III, John C. Somberg, and James T. ODonnellSECTION I OverviewChapter 2: Current Opinions on the Trajectory of the Pharmaceutical DevelopmentJohn C. SombergChapter 3: Innovation in Drug Development: Perspectives of a Venture CapitalistKrishna YeshwantSECTION II Drug DiscoveryChapter 4: High-Throughput ScreeningOlivia Perez, J. Pena, Virneliz Fernandez-Vega, Louis Scampavia, and Timothy SpicerChapter 5: DNA-Encoded Compound Libraries: An Emerging Paradigm in Drug Hit DiscoveryRaphael M. FranziniChapter 6: Bio-Targeted Nanomaterials for Theranostic ApplicationsSabyasachi Maiti and Kalyan Kumar SenChapter 7: The Development of Adoptive T-Cell Immunotherapies for Cancer: Challenges and ProspectsDavid J. Dow, Steven J. Howe, Mala K. Talekar, and Laura A. JohnsonChapter 8: CRISPR in Drug DiscoveryChih-Shia Lee and Ji LuoChapter 9: Probiotics in the World: Bugs-as-DrugsThomas Kuntz, Madeline Kim, Elle Simone Hill, Mariana C. Salas Garcia, and Jack A. GilbertChapter 10: Discovery and Early Development of the Next-Generation ALK Inhibitor, Lorlatinib (18): Agent for Non·Small-Cell Lung CancerPaul F. RichardsonSECTION III Drug DevelopmentChapter 11: Integrated Drug Product Development: From Lead Candidate Selection to Life-Cycle ManagementMadhu Pudipeddi, Abu T.M. Serajuddin, Ankita V. Shah, and Daniel MufsonChapter 12: New Trends in Pharmacological and Pharmaceutical ProfilingLyn Rosenbrier Ribeiro, Duncan Armstrong, Thierry Jean, and Jean-Pierre ValentinChapter 13: Pharmacokinetics·Pharmacodynamics in New Drug DevelopmentSarfaraz K. NiaziChapter 14: The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport MechanismsJibin Li and Ismael J. HidalgoChapter 15: Preclinical ToxicologyDamani ParranChapter 16: Safety Pharmacology: Past, Present, and FutureJean-Pierre Valentin, Annie Delaunois, Marie-Luce Rosseels, Vitalina Gryshkova, and Tim G. HammondChapter 17: Ethical Concerns in Clinical ResearchJonathan C. Young and Lori NesbittChapter 18: Clinical Trials MethodologyJohn SombergChapter 19: The Academic Research EnterpriseCrista Brawley, Mary Jane Welch, Jeff Oswald, Erin Kampschmidt, Jennifer Garcia, Allecia Harley, Shrijay Vijayan, John McClatchy, Stephanie Guzik, and Stephanie TedfordChapter 20: Clinical Testing Challenges in HIV/AIDS ResearchVincent IdemyorChapter 21: The Evolving Role of the Pharmacist in Clinical, Academic, and Industry SectorsGourang Patel and Stephanie TedfordChapter 22: Intellectual Property in the Drug Discovery ProcessMartha M. Rumore and William SchmidtChapter 23: Drug Repurposing: Academic Clinician Research EndeavorsKathleen Heneghan and Stephanie E. TedfordSECTION IV RegulationsChapter 24: The Role of the Regulatory Affairs Professional in Guiding New Drug Research, Development, and ApprovalS. Albert EdwardsChapter 25: Orphan Drug Development and RegulationsA.M. LynchChapter 26: Development of Drug Products for Older Adults: Challenges, Solutions, and Regulatory ConsiderationsS.W. Johnny Lau, Darrell R. Abernethy, and Chandrahas SahajwallaChapter 27: Clinical Pharmacology and Regulatory Concerns for Developing Drug Products for Pediatric PatientsJanelle M. Burnham and Gilbert J. BurckartChapter 28: Pharmacy Compounding RegulationsLoyd V. Allen, Jr. and Willis C. TriplettIndex