Bibliographic record and links to related information available from the Library of Congress catalog.
Note: Contents data are machine generated based on pre-publication provided by the publisher. Contents may have variations from the printed book or be incomplete or contain other coding.
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 Evaluation, Preclinical.