Atkinson's Principles of Clinical Pharmacology

Atkinson's Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology.

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

Shiew-Mei Huang, PhD, FCP, is Deputy Director at the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration. She received her BS in pharmacy from National Taiwan University, School of Pharmacy in 1975, and her PhD from the University of Illinois, Medical Center in Pharmacokinetics and Biopharmaceutics in 1981. She has more than 15 years of drug development experience (Ortho pharmaceutical and Dupont-Merck) before joining the FDA in 1996. She has more than 160 publications focusing on topics in clinical pharmacology, drug metabolism/transport interactions, and physiologically based pharmacokinetic modeling and pharmacogenomics areas. Dr. Huang is a fellow of the American Association of Pharmaceutical Scientists and a diplomate of the American Board of Clinical Pharmacology. She was President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) from 2009 to 2010. She received ASCPT Awards "Gary Neil Prize for Innovation in Drug Development in March 2014 and "Henry Elliott Distinguished Service Award in March 2016.
Juan J. L. Lertora, MD, PhD, is Adjunct Professor of Clinical Research at the Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, and Adjunct Professor of Medicine at the Duke University School of Medicine, Durham, NC. He is a former Director of the Clinical Pharmacology Program at the NIH Clinical Center in Bethesda, MD. As a junior faculty at the Clinical Pharmacology Center, Northwestern University School of Medicine in Chicago, he received a PMA Foundation Faculty Development Award in Clinical Pharmacology. Subsequently, he became Section Head of Clinical Pharmacology at the Tulane University School of Medicine in New Orleans. In 2010 Dr. Lertora was distinguished with the NIH Director Ruth L. Kirschstein Mentoring Award. He is also a recipient of the 2013 PhRMA Foundation Award in Excellence in Clinical Pharmacology, and the 2014 Henry W. Elliott Distinguished Service Award from the American Society for Clinical Pharmacology and Therapeutics.
Paolo Vicini, PhD, MBA, is Chief Development Officer at Confo Therapeutics, Ghent, Belgium. He is also Affiliate Associate Professor of Bioengineering at the University of Washington, Seattle. He was previously Vice President of Development Sciences at Kymab; Senior Director of Clinical Pharmacology, Pharmacometrics and DMPK with MedImmune Cambridge (UK); and Research Fellow in Pharmacokinetics, Dynamics, and Metabolism with Pfizer in San Diego. Before Pfizer, he was a bioengineering faculty member at the University of Washington. He is Fellow of the American Association of Pharmaceutical Scientists and a member of many other professional organizations. Dr. Vicini has direct experience in translational and clinical sciences through all phases of drug discovery and development and coauthored more than 150 scholarly publications. He holds a PhD in bioengineering from the Polytechnic of Milan and an MBA from the University of Southern California.
Arthur J. Atkinson, Jr., M.D., M.A.C.P., is Adjunct Professor of Pharmacology at the Feinberg Medical School of Northwestern University. He has held leadership roles in clinical pharmacology for more than 50 years, working in both academia and the pharmaceutical industry, and for NIH. He founded and for 24 years directed a Clinical Pharmacology Center at Northwestern, rising to the rank of Professor of Pharmacology and Medicine. He was subsequently Corporate Vice President for Clinical Development and Medical Affairs at the Upjohn Company. Following the Upjohn-Pharmacia merger, he was recruited to be Senior Advisor in Clinical Pharmacology at the NIH Clinical Center. There, he initiated a clinical pharmacology course and served as lead editor for the previous three editions of Principles of Clinical Pharmacology, the required text for the course. Dr. Atkinson has been elected Master of the American College of Physicians and to membership in the American Association of Physicians. He received the Harry Gold Award from ASPET, the Oscar Hunter Award from ASCPT, and the Award in Excellence from the PhRMA Foundation.