Table of contents for The process of new drug discovery and development / editors, Charles G. Smith and James O'Donnell.

Bibliographic record and links to related information available from the Library of Congress catalog.

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SECTION I: GENERAL OVERVIEW
Chapter 1: (Reprint) Introduction 
By Charles G. Smith, PhD 
Chapter 2: Overview of The Process of New Drug Discovery and Development, Second Edition
By Charles G. Smith, PhD; and James T. O'Donnell, PharmD, MS
Chapter 3: Integrated Product Development: From Lead Candidate Selection to Life-Cycle Management 
By Madhu Pudipeddi, Abu T.M. Serajuddin, PhD; and Daniel Mufson, PhD
 
SECTION II: SCIENTIFIC DISCOVERIES APPLICATION IN NEW DRUG DEVELOPMENT
 
Chapter 4: Combinatorial Chemistry
By Michael H. Rabinowitz, PhD; and Nigel Shankley, PhD 
Chapter 5: High-Throughput Screening: Enabling and Influencing the Process of Drug Discovery
By Carol Ann Homon, MS; and Richard M. Nelson, PhD
Chapter 6: Pharmacological And Pharmaceutical Profiling: New Trends
Part 1, by Joanne Bowes, PhD; Michael G. Rolf, PhD; and Jean-Pierre Valentin, PhD 
Part 2, by Valérie Hamon, PhD; Mark Crawford, PhD; and Thierry Jean, PhD 
Chapter 7: Cell-Based Analysis of Drug Response Using Moving Optical Gradient Fields
By Jeff M. Hall, PhD; Ilona Kariv, PhD; Patricia A. McNeeley; Phillip J Marchand; and Tina S. Nova, PhD 
Chapter 8: Patient-Derived Primary Cells in High-Throughput Differential Anti-Tumor Screens: Let the Patients Be the Guide
By Irwin Braude, DSc
 
Chapter 9: The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms
By Jibin Li and Ismael J. Hidalgo, PhD
Chapter 10: The Promise of Metabonomics in Drug Discovery
By Harold J. Kwalwasser; and Pauline Gee, PhD
Chapter 11: Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop
By Lawrence J. Lesko, PhD; Ronald A. Salerno, PhD; Brian B. Spear, PhD; Donald C. Anderson, MD; Timothy Anderson, PhD; Celia Brazell, PhD; Jerry Collins, PhD; Andrew Dorner, PhD; David Essayan, MD; Baltazar Gomez-Mancilla, MD, PhD; Joseph Hackett, PhD; Shiew-Mei Huang, PhD; Susan Ide, PhD; Joanne Killinger, PhD; John Leighton, PhD; Elizabeth Mansfield, PhD; Robert Meyer, MD; Stephen G. Ryan, MD; Virginia Schmith, PhD; Peter Shaw, PhD; Frank Sistare, PhD; Mark Watson, MD, PhD; and Alexandra Worobec, MD
Chapter 12: Drugs from Molecular Targets for CNS and Neurodegenerative Diseases
By William T. Comer, PhD; and Gönül Veliçelebi, PhD 
Chapter 13: Safety Pharmacology 
By Jean-Pierre Valentin, PhD
Chapter 14: Nonclinical Drug Safety Assessment
By Frederick E. Reno, PhD 
Chapter 15: Preclinical Genotoxicity Testing¿Past, Present and Future
By Richard H.C. San, PhD
SECTION THREE: STANDARD DRUG DEVELOPMENTAL ISSUES: UPDATED
Chapter 16: The Need for Animals in Biomedical Research 
By Charles G. Smith, PhD 
Chapter 17: Defining the Actual Research Approach to the New Drug Substance
By Charles G. Smith, PhD
Chapter 18: 
By Sarfaraz K. Niazi, Ph.D.
a) Good Pharmacokinetic Practice to Streamline New Drug Development
b) Pharmacokinetic/Pharmacodynamic Modeling in New Drug Development
Chapter 19: Pharmaceutics And Compounding Issues In New Drug Development And Marketing
By Loyd V. Allen, Jr., PhD
Chapter 20: Late Stage and Process Development Activities
By Charles Smith, PhD
 
SECTION FOUR: CLINICAL DEVELOPMENT 
Chapter 21: Contract Research Organizations: Role and Function in New Drug Development
By F. Richard Nichol, Jr., PhD
Chapter 22: The Front Lines of Clinical Research: The Industry 
By Lori Nesbitt, PharmD, MBA
Chapter 23: Horizons for Cancer Chemotherapy (and non-Chemotherapy)
By Daniel D. Von Hoff, MD, FACP
Chapter 24: Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) Clinical Testing Challenges
By Vincent Idemyor, PharmD
SECTION FIVE: REGULATORY AND LEGAL ISSUES AFFECTING DRUG DEVELOPMENT  
Chapter 25: CTD: The Changing Face of the NDA
By Justina Molzon, MS Pharm, JD
Chapter 26: Electronic Publishing 
By Heather Leigh Wallace 
Chapter 27: The Important Role of Pharmacists in a Complex Risk Management System: Managing the Risks from Medical Product Use by Focusing on Patient Education, Monitoring, and Adverse Event Reporting
By Justina Molzon, MS Pharm, JD
Chapter 28: Liability, Litigation, and Lessons in New Drug Development
By James T. O'Donnell, PharmD, MS
Chapter 29: Problems in the Non-Drug Marketplace
By Stephen Barrett, MD 
Chapter 30: Patents and New Product Development in the Pharmaceutical and Biotechnology Industries
By Henry Grabowski, PhD
Chapter 31: The Pharmaceutical Revolution: Drug Discovery and Development 
By John C. Somberg, MD
SECTION SIX: CASE HISTORIES
Chapter 32: The Discovery of Rituxan
By Mitchell E. Reff, PhD
Chapter 33: Funding the Birth of a Drug: Lessons from the "Sell" Side
By Howard E. (Ted) Greene, Jr.
Chapter 34: Innovations for the Drug Development Pathway: What Is Needed Now
Janet Woodcock, MD
Chapter 35: 
By Mark Paich, PhD; Corey Peck; Jason Valant, Kirk Solo
a) Using Dynamic Modeling to Assess and Maximize Commercial Potential of Developmental Drug Compounds
b) Risk Assessment and Addressing Uncertainty in Pharmaceutical New Drug Discovery and Development

Library of Congress Subject Headings for this publication:

Drugs -- Research -- History.
Drugs -- Design -- History.
Drug Design.
Drug Evaluation, Preclinical.
Drug Evaluation.