Drug Discovery and Development, Third Edition

ISBN-13: 9781032084244 / Angielski / Miękka / 2021 / 696 str.

James J. O'Donnell; John Somberg; Vincent Idemyor

Opis

The third edition of The Process of New Drug Discovery and Development presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace.

Spis treści

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

O autorze

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