Translating Molecules into Medicines

Part I. Discovery, Development and Commercialization of Drug Candidates: Overview and Issues

1. Pharmaceutical Industry Performance
David C. Swinney

2. New Product Planning and the Drug Discovery-Development Interface
Robin Reagan

Part II. Druggable Targets, Discovery Technologies and Generation of Lead Molecules

3. Target Engagement Measures in Preclinical Drug Discovery: Theory, Methods, and Case Studies
Timothy B. Durham, Michael R. Wiley

4. In Silico ADME Techniques Used in Early-Phase Drug Discovery
Matthew L. Danielson, Bingjie Hu, Jie Shen, Prashant V. Desai

5. Discover Toxicology: An Early Safety Assessment Approach
Thomas K. Baker, Steven K. Engle, Bartley W. Halstead, Brianna M. Paisley, George H. Searfoss, Jeffrey A. Willy

Part III. Optimizing Lead Molecules into Drug Candidates

6. Integrated Lead Optimization: Translational Models as We Advance Toward the Clinic
Bianca M. Liederer, Xingrong Liu, Simon Wong, Daniel R. Mudra

7. Developability Assessment of Clinical Candidates
Shobha N. Bhattachar, Jeffrey S. Tan, David M. Bender

8. Lead Optimization, Preclinical Toxicology
Marcus H. Andrews, Vincent L. Reynolds

Part IV. Early Clinical Development of Drug Candidates

9. Design of Clinical Studies in Early Development
Margaret S. Landis

10. Design of Clinical Formulations in Early Development
Catherine M. Ambler, Avinash G. Thombre, Madhushree Gokhale, John S. Morrison

11. Translational Research: Preclinical to Healthy Volunteer to Patient
Brinda Tammara, Sangeeta Raje, William McKeand, Joan M. Korth-Bradley

12. Regulatory Aspects at the Drug Discovery Development Interface
Lynn Gold, Ken Phelps

Part V. Evolution of the Drug Discovery/Development Paradigm

13. Alternate Routes of Administration
Neil Mathias, Srini Sridharan

14. Outlook for the Future
John S. Morrison, Michael J. Hageman

Keywords: Biomedicine, Pharmaceutical Sciences/Technology