Atkinson's Principles of Clinical Pharmacology

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.

• 1. Introduction to Clinical PharmacologyArthur John Atkinson Jr., Juan J. L. Lertora and Shiew Mei Huang2. Clinical PharmacokineticsArthur John Atkinson Jr.3. Compartmental Analysis of Drug DistributionArthur John Atkinson Jr.4. Drug Absorption and BioavailabilityArthur John Atkinson Jr.5. Effect of Renal Disease on PharmacokineticsThomas D. Nolin, Albert Dreisbach and Juan J. L. Lertora6. Pharmacokinetics in Patients Requiring Renal Replacement TherapyArthur John Atkinson Jr., Thomas D. Nolin and John Allen7. Effect of Liver Disease on PharmacokineticsJuan J. L. Lertora, Robert A. Branch and Nathalie K. Zgheib8. Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data AnalysisPaolo Vicini9. Population PharmacokineticsRaymond Miller and Ophelia Yin10. Pathways of Drug MetabolismNina Isoherranen and R. Scott Obach11. Methods of Analysis of Drugs and Drug MetabolitesMark Edward Arnold and Brian Booth12. Clinical PharmacogenomicsAnuradha Ramamoorthy, Tristan Sissung and Michael Pacanowski13. Mechanisms and genetics of drug transportLei Zhang, Sook Wah Yee, Osatohanmwen Enogieru, Shiew Mei Huang and Kathleen Giacomini14. drug-drug interactionsAleksandra Galetin, Lei Zhang, A. David Rodrigues and Shiew Mei Huang15. Biochemical Mechanisms of Drug ToxicityArthur John Atkinson Jr., Jack Uetrecht, Denis M. Grant and Peter G. Wells16. pharmacogenomic mechanisms of drug toxicityShiew Mei Huang, Ligong Chen and Kathleen Giacomini17. Biomarkers in Drug DevelopmentRobert N. Schuck, Jana G. Delfino, Christopher Leptak and John A. Wagner18. imaging in drug developmentOwen Carmichael19. dose-effect and concentration-effect analysisJuan J. L. Lertora, Yaning Wang, Jiang Liu and Justin C. Earp20. time course of drug responseNick Holford21. disease progress modelsDiane Renee Mould, Nick Holford and Carl Peck22. Pharmacological Differences between Men and WomenMary F. Paine and Karen Dinh Vo23. drug therapy in pregnant and nursing womenCatherine Stika and Marilynn C. Frederiksen24. pediatric clinical pharmacology and therapeuticsBridgette Jones, John N. van den Anker, Gilbert J. Burckart and Gregory Kearns25. Medication Therapy in Older AdultsS. W. Johnny Lau, Danijela Gnjidic and Darrell Abernethy26. clinical analysis of adverse drug reactionsChristine Chamberlain, Cindy Kortepeter and Monica Munoz27. Quality Assessment of Drug TherapyCharles Edward Daniels28. portfolio and project planning and management in the drug discovery evaluation, development, and regulatory review processCharles V. Grudzinskas, Michael Dyszel, Khushboo Sharma and Charles T. Gombar29. Drug DiscoveryThomas Bateman30. Non-Clinical Drug DevelopmentChris H. Takimoto31. pre-clinical prediction of human pharmacokineticsMalcolm Rowland32. Phase I Clinical StudiesRobert Joseph Noveck and Martina D. Sahre33. pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large moleculesPamela Garzone and Yow-Ming C. Wang34. Design of Clinical Development ProgramsMegan Gibbs, Bengt Hamren, Helen Tomkinson, Renee Bailey Iacona and David Boulton35. the role of the FDA in guiding drug development;Elimika Pfuma Fletcher, Rajanikanth Madabushi, Chandrahas Sahajwalla, Lawrence J. Lesko and Shiew Mei Huang36. Emerging Clinical Pharmacology Topics in Drug Development and Precision MedicineQi Liu, Jack A. Gilbert, Hao Zhu, Shiew Mei Huang, Elizabeth Kunkoski, Promi Das, Kimberly Bergman, Mary Buschmann and M Khair ElZarradAppendix IAppendix II