Drug Discovery and Development, Third Edition
Editat de James J. O'Donnell, John Somberg, Vincent Idemyor, James T. O'Donnellen Limba Engleză Paperback – 30 iun 2021
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 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
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Specificații
ISBN-13: 9781032084244
ISBN-10: 1032084243
Pagini: 696
Ilustrații: 98
Dimensiuni: 178 x 254 x 39 mm
Greutate: 1.28 kg
Ediția:3
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
ISBN-10: 1032084243
Pagini: 696
Ilustrații: 98
Dimensiuni: 178 x 254 x 39 mm
Greutate: 1.28 kg
Ediția:3
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
Public țintă
Academic and Professional Practice & DevelopmentRecenzii
This third edition, written by experts from around the world, is expected to be useful for scientists working in this field. Each team in the drug discovery and development group will find some useful information in this book. There are many books in this area, but this one appears to discuss the topics in a bit greater detail.
- Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler
- Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler
Notă biografică
James J. O'Donnell, James T. O'Donnell
Descriere
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.
Cuprins
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
Omar 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
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
Omar 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