The Process of New Drug Discovery and Development, Second Edition 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. This new addition updates the scientific advances in new drug discovery and development for areas

chapter 1|6 pages


ByCharles G. Smith

chapter 2|8 pages

Overview of the Current Process of New Drug Discovery and Development

ByCharles G. Smith and James T. O’Donnell

chapter 3|40 pages

Integrated Drug Product Development — From Lead Candidate Selection to Life-Cycle Management

ByMadhu Pudipeddi, Abu T.M. Serajuddin, and Daniel Mufson

chapter 4|24 pages

The Impact of Combinatorial Chemistry on Drug Discovery

ByMichael H. Rabinowitz, Nigel Shankley

chapter 5|24 pages

High-Throughput Screening: Enabling and Influencing the Process of Drug Discovery

ByCarol Ann Homon, Richard M. Nelson

chapter 6|32 pages

Pharmacological and Pharmaceutical Profiling: New Trends

ByJoanne Bowes, Michael G. Rolf, Jean-Pierre Valentin, Valérie Hamon, Mark Crawford, Thierry Jean

chapter 7|14 pages

Cell-Based Analysis of Drug Response Using Moving Optical Gradient Fields

ByJeff M. Hall, Ilona Kariv, Patricia A. McNeeley, Phillip J. Marchand, Tina S. Nova

chapter 10|12 pages

The Promise of Metabonomics in Drug Discovery

ByHarold J. Kwalwasser, Pauline Gee

chapter 11|26 pages

Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision-Making: Report of the First FDA–PWG– PhRMA–DruSafe Workshop

ByLawrence J. Lesko, Ronald A. Salerno, Brian B. Spear, Donald C. Anderson, Timothy Anderson, Celia Brazell, Jerry Collins, Andrew Dorner, David Essayan, Baltazar Gomez-Mancilla, Joseph Hackett, Shiew-Mei Huang, Susan Ide, Joanne Killinger, John Leighton, Elizabeth Mansfield, Robert Meyer, Stephen G. Ryan, Virginia Schmith, Peter Shaw, Frank Sistare, Mark Watson, Alexandra Worobec

chapter 12|18 pages

Drugs from Molecular Targets for CNS and Neurodegenerative Diseases

ByWilliam T. Comer, Gönül Veliçelebi

chapter 13|48 pages

Safety Pharmacology: Past, Present, and Future

ByJean-Pierre Valentin, Tim G. Hammond

chapter 14|14 pages

Nonclinical Drug Safety Assessment

ByFrederick E. Reno

chapter 15|10 pages

Preclinical Genotoxicity Testing — Past, Present, and Future

ByRichard H.C. San

chapter 16|14 pages

The Need for Animals in Biomedical Research

ByCharles G. Smith

chapter 17|6 pages

Defining the Actual Research Approach to the New Drug Substance

ByCharles G. Smith

chapter 18|42 pages

Pharmacokinetics –– Pharmacodynamics in New Drug Development

BySarfaraz K. Niazi

chapter 20|6 pages

Late Stage and Process Development Activities

ByCharles G. Smith

chapter 21|12 pages

Contract Research Organizations: Role and Function in New Drug Development

ByF. Richard Nichol

chapter 22|26 pages

The Front Lines of Clinical Research: The Industry

ByLori Nesbitt

chapter 23|14 pages

Horizons for Cancer Chemotherapy (and Nonchemotherapy)

ByDaniel D. Von Hoff

chapter 25|8 pages

Common Technical Document: The Changing Face of the New Drug Application

ByJustina A. Molzon

chapter 26|2 pages

Electronic Publishing

ByHeather L. Wallace

chapter 28|32 pages

Liability, Litigation, and Lessons in New Drug Development

ByJames T. O’Donnell

chapter 29|12 pages

Problems in the Nondrug Marketplace

ByStephen Barrett

chapter 31|18 pages

The Pharmaceutical Revolution: Drug Discovery and Development

ByJohn C. Somberg

chapter 32|20 pages

The Discovery of Rituxan

ByMitchell E. Reff

chapter 33|18 pages

Funding the Birth of a Drug: Lessons from the Sell Side

ByHoward E. Greene

chapter 34|14 pages

Innovations for the Drug Development Pathway: What Is Needed Now

ByJanet Woodcock