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. 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.

• Chapter 1 IntroductionPART 1: PHARMACOKINETICS:Chapter 2 Clinical pharmacokinetics Chapter 3 Compartmental analysis of drug distribution Chapter 4 Drug absorption and bioavailability Chapter 5 Effects of renal disease on pharmacokineticsChapter 6 Kinetics of hemodialysis and hemofiltrationChapter 7 Effects of liver disease on pharmacokineticsChapter 8 Noncompartmental vs. compartmental approaches to pharmacokinetic analysisChapter 9 Distributed models of drug kineticsChapter 10 Population pharmacokineticsPART 2: DRUG METABOLISM AND TRANSPORT:Chapter 11 Pathways of drug metabolismChapter 12 Biochemical mechanisms of drug toxicityChapter 13 Chemical assay of drugs and drug metabolitesChapter 14 Equilibrative and concentrative transportChapter 15 PharmacogeneticsChapter 16 Drug interactionsPART 3: ASSESSMENT OF DRUG EFFECTS:Chapter 17 Physiological and laboratory markers of drug effectChapter 18 Dose response and concentration response analysisChapter 19 Kinetics of pharmacologic effectChapter 20 Disease progression models PART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY:Chapter 21 Sex differences in pharmacokinetics and pharmacodynamicsChapter 22 Drug therapy in pregnant and nursing womenChapter 23 Drug therapy in neonates and pediatric patientsChapter 24 Drug therapy in the elderlyChapter 25 Clinical analysis of adverse drug reactionsChapter 26 Quality assessment of drug therapyPART 5: DRUG DISCOVERY AND DEVELOPMENT:Chapter 27 Project managementChapter 28 Drug discoveryChapter 29 Pre-clinical developmentChapter 30 Animal scale upChapter 31 Phase I studiesChapter 32 PK and PD considerations in the development of biotechnology products and large moleculesChapter 33 Design of clinical development programsChapter 34 Good design practices for clinical trials Chapter 35 Role of the FDA in guiding drug developmentAppendix I Table of Laplace TransformsAppendix II Answers to Study Problems

"…this is an excellent textbook that provides a comprehensive overview of the fundamentals and state of the art of clinical pharmacology. It will be an invaluable reference source for many current and future scientists in the field." --Clinical Pharmacology and Therapeutics, June 2013"Recent advances in pharmacogenetics, membrane transport, and biotechnology warrant a second edition of this excellent book...This will serve as an excellent text for an advanced course in principles of clinical pharmacology for graduate students, physicians, and PharmDs. Because of recent advances, the second edition is welcome. (4 Stars)" --Doody's