1. Introduction to Clinical Pharmacology

Arthur John Atkinson Jr., Juan J. L. Lertora and Shiew Mei Huang

2. Clinical Pharmacokinetics

Arthur John Atkinson Jr.

3. Compartmental Analysis of Drug Distribution

Arthur John Atkinson Jr.

4. Drug Absorption and Bioavailability

Arthur John Atkinson Jr.

5. Effect of Renal Disease on Pharmacokinetics

Thomas D. Nolin, Albert Dreisbach and Juan J. L. Lertora

6. Pharmacokinetics in Patients Requiring Renal Replacement Therapy

Arthur John Atkinson Jr., Thomas D. Nolin and John Allen

7. Effect of Liver Disease on Pharmacokinetics

Juan J. L. Lertora, Robert A. Branch and Nathalie K. Zgheib

8. Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data Analysis

Paolo Vicini

9. Population Pharmacokinetics

Raymond Miller and Ophelia Yin

10. Pathways of Drug Metabolism

Nina Isoherranen and R. Scott Obach

11. Methods of Analysis of Drugs and Drug Metabolites

Mark Edward Arnold and Brian Booth

12. Clinical Pharmacogenomics

Anuradha Ramamoorthy, Tristan Sissung and Michael Pacanowski

13. Mechanisms and genetics of drug transport

Lei Zhang, Sook Wah Yee, Osatohanmwen Enogieru, Shiew Mei Huang and Kathleen Giacomini

14. drug-drug interactions

Aleksandra Galetin, Lei Zhang, A. David Rodrigues and Shiew Mei Huang

15. Biochemical Mechanisms of Drug Toxicity

Arthur John Atkinson Jr., Jack Uetrecht, Denis M. Grant and Peter G. Wells

16. pharmacogenomic mechanisms of drug toxicity

Shiew Mei Huang, Ligong Chen and Kathleen Giacomini

17. Biomarkers in Drug Development

Robert N. Schuck, Jana G. Delfino, Christopher Leptak and John A. Wagner

18. imaging in drug development

Owen Carmichael

19. dose-effect and concentration-effect analysis

Juan J. L. Lertora, Yaning Wang, Jiang Liu and Justin C. Earp

20. time course of drug response

Nick Holford

21. disease progress models

Diane Renee Mould, Nick Holford and Carl Peck

22. Pharmacological Differences between Men and Women

Mary F. Paine and Karen Dinh Vo

23. drug therapy in pregnant and nursing women

Catherine Stika and Marilynn C. Frederiksen

24. pediatric clinical pharmacology and therapeutics

Bridgette Jones, John N. van den Anker, Gilbert J. Burckart and Gregory Kearns

25. Medication Therapy in Older Adults

S. W. Johnny Lau, Danijela Gnjidic and Darrell Abernethy

26. clinical analysis of adverse drug reactions

Christine Chamberlain, Cindy Kortepeter and Monica Munoz

27. Quality Assessment of Drug Therapy

Charles Edward Daniels

28. portfolio and project planning and management in the drug discovery evaluation, development, and regulatory review process

Charles V. Grudzinskas, Michael Dyszel, Khushboo Sharma and Charles T. Gombar

29. Drug Discovery

Thomas Bateman

30. Non-Clinical Drug Development

Chris H. Takimoto

31. pre-clinical prediction of human pharmacokinetics

Malcolm Rowland

32. Phase I Clinical Studies

Robert Joseph Noveck and Martina D. Sahre

33. pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large molecules

Pamela Garzone and Yow-Ming C. Wang

34. Design of Clinical Development Programs

Megan Gibbs, Bengt Hamren, Helen Tomkinson, Renee Bailey Iacona and David Boulton

35. the role of the FDA in guiding drug development;

Elimika Pfuma Fletcher, Rajanikanth Madabushi, Chandrahas Sahajwalla, Lawrence J. Lesko and Shiew Mei Huang

36. Emerging Clinical Pharmacology Topics in Drug Development and Precision Medicine

Qi Liu, Jack A. Gilbert, Hao Zhu, Shiew Mei Huang, Elizabeth Kunkoski, Promi Das, Kimberly Bergman, Mary Buschmann and M Khair ElZarrad

Appendix I

Appendix II