A valuable resource covering the science of drug discovery and development as it relates to individual patient therapy
Chapter 1 Introduction
PART 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 pharmacokinetics
Chapter 6 Kinetics of hemodialysis and hemofiltration
Chapter 7 Effects of liver disease on pharmacokinetics
Chapter 8 Noncompartmental vs. compartmental approaches to
pharmacokinetic analysis
Chapter 9 Distributed models of drug kinetics
Chapter 10 Population pharmacokinetics
PART 2: DRUG METABOLISM AND TRANSPORT:
Chapter 11 Pathways of drug metabolism
Chapter 12 Biochemical mechanisms of drug toxicity
Chapter 13 Chemical assay of drugs and drug metabolites
Chapter 14 Equilibrative and concentrative transport
Chapter 15 Pharmacogenetics
Chapter 16 Drug interactions
PART 3: ASSESSMENT OF DRUG EFFECTS:
Chapter 17 Physiological and laboratory markers of drug effect
Chapter 18 Dose response and concentration response analysis
Chapter 19 Kinetics of pharmacologic effect
Chapter 20 Disease progression models
PART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY:
Chapter 21 Sex differences in pharmacokinetics and
pharmacodynamics
Chapter 22 Drug therapy in pregnant and nursing women
Chapter 23 Drug therapy in neonates and pediatric patients
Chapter 24 Drug therapy in the elderly
Chapter 25 Clinical analysis of adverse drug reactions
Chapter 26 Quality assessment of drug therapy
PART 5: DRUG DISCOVERY AND DEVELOPMENT:
Chapter 27 Project management
Chapter 28 Drug discovery
Chapter 29 Pre-clinical development
Chapter 30 Animal scale up
Chapter 31 Phase I studies
Chapter 32 PK and PD considerations in the development of
biotechnology products and large molecules
Chapter 33 Design of clinical development programs
Chapter 34 Good design practices for clinical trials
Chapter 35 Role of the FDA in guiding drug development
Appendix I Table of Laplace Transforms
Appendix II Answers to Study Problems
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.
".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 & 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."--Thomas L. Pazdernik, PhD, University of Kansas Medical Center, FOR DOODY'S (4 Stars)
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