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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.
- Presents the essential knowledge for effective practice of clinical pharmacology
- Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology
- Offers an extensive regulatory section that addresses US and international issues and guidelines
- Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK
Clinical pharmacologists, pharmacologists, clinicians and scientists working in the pharmaceutical industry and government regulatory agencies
PART 1: PHARMACOKINETICS
2. Clinical pharmacokinetics
3. Compartmental analysis of drug distribution
4. Drug absorption and bioavailability
5. Effects of renal disease on pharmacokinetics
6. Kinetics of hemodialysis and hemofiltration
7. Effects of liver disease on pharmacokinetics
8. Noncompartmental vs. compartmental approaches to pharmacokinetic analysis
9. Distributed models of drug kinetics
10. Population pharmacokinetics
PART 2: DRUG METABOLISM AND TRANSPORT
11. Pathways of drug metabolism
12. Biochemical mechanisms of drug toxicity
13. Chemical assay of drugs and drug metabolites
14. Equilibrative and concentrative transport
16. Drug interactions
PART 3: ASSESSMENT OF DRUG EFFECTS
17. Physiological and laboratory markers of drug effect
18. Dose response and concentration response analysis
19. Kinetics of pharmacologic effect
20. Disease progression models
PART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY
21. Sex differences in pharmacokinetics and pharmacodynamics
22. Drug therapy in pregnant and nursing women
23. Drug therapy in neonates and pediatric patients
24. Drug therapy in the elderly
25. Clinical analysis of adverse drug reactions
26. Quality assessment of drug therapy
PART 5: DRUG DISCOVERY AND DEVELOPMENT
27. Project management
28. Drug discovery
29. Pre-clinical development
30. Animal scale up
31. Phase I studies
32. PK and PD considerations in the development of biotechnology products and large molecules
33. Design of clinical development programs
34. Good design practices for clinical trials
35. Role of the FDA in guiding drug development
I. Table of Laplace Transforms
II. Answers to Study Problems
- No. of pages:
- © Academic Press 2021
- 24th September 2021
- Academic Press
- Hardcover ISBN:
Shiew-Mei Huang, PhD, FCP is Acting Director at the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation Research (CDER), Food and Drug Administration (FDA) in Silver Spring, MD. She is also an Adjunct Professor in the Department of Pharmaceutical Sciences at the University of Maryland, School of Pharmacy, in Baltimore, MD. Since joining OCP, she has assumed responsibility for a wide variety of scientific activities relating to review, policy development, research and scientific communications. She has also managed several extramural research projects in the areas of drug metabolism, drug-drug and drug-herb interactions, and pharmacogenetics. She has published numerous peer-reviewed articles and book chapters focusing on the topics of clinical pharmacology, drug metabolism/transport and drug interactions, pharmacogenetics and biomarker areas. Dr. Huang is currently an Associate Editor for Clinical Pharmacology and Therapeutics and is on the editorial board of several additional journals.
Acting Director, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation Research (CDER), Food and Drug Administration (FDA) in Silver Spring, MD, USA
Juan Lertora, MD, PhD, is Adjunct Professor in the Department of Medicine, Duke University, Durham, NC. He was previously director of the Clinical Pharmacology Program at the NIH Clinical Center. He attended the Faculty of Medicine, National University of the Northeast, Argentina (M.D.) and Tulane University, New Orleans, Louisiana (Ph.D. in Pharmacology). He received the 2013 PhRMA Foundation Award in Excellence in Clinical Pharmacology from the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Lertora was awarded a PhRMA Foundation Faculty Development Award in Clinical Pharmacology while teaching pharmacology at Northwestern University. He received a PMA Foundation Clinical Pharmacology Unit Award as an Associate Professor of Medicine and Pharmacology and Section Head of Clinical Pharmacology at the Tulane University School of Medicine. He received the NIH Clinical Center Director’s Award for Teaching and Training in 2008.
Adjunct Professor, Department of Medicine, Duke University, Durham, NC, USA
Paolo Vicini, PhD, is Vice President, Development Sciences, Kymab Ltd., MedImmune Limited, Cambridge, Department of Clinical Pharmacology, Cambridge. He has in-depth leadership and scientific experience in pharmaceutical and academic R&D, teaching and training, consulting and business education. He has more than 130 scholarly publications in diverse areas such as: oncology targeted agents, diabetes, immunotherapy and immunogenicity, dose optimization, maternal-fetal and pediatric pharmacology. Dr. Vicini has direct experience in translational and clinical sciences through all phases of drug discovery and development.
Vice President, Development Sciences, Kymab Ltd., MedImmune Limited and Department of Clinical Pharmacology, Cambridge, UK
Dr. Atkinson received his A.B. degree in Chemistry from Harvard College in 1959 and his M.D. from Cornell University Medical College in 1963. Following medical internship and residency at the Massachusetts General Hospital, he was a Clinical Associate in the Laboratory of Clinical Investigation of the National Institute of Allergy and Infectious Diseases at NIH. He subsequently received postdoctoral training in clinical pharmacology at the University of Cincinnati and was a Visiting Scientist in the Department of Toxicology at the Karolinska Institute before moving to Northwestern University Medical School in 1970 to start the program in clinical pharmacology. While at Northwestern, he and his colleagues set up the first U.S. hospital laboratory devoted to general therapeutic drug monitoring, designed and conducted the first clinical investigations to develop the acetylated metabolite of procainamide as a new antiarrhythmic drug, carried out the first pharmacokinetic studies with stable isotope-labeled drugs, and completed basic research that elucidated the physiologic basis of some multicompartmental models of drug distribution. In 1994, Dr. Atkinson was appointed Corporate Vice President for Clinical Development and Medical Affairs at the Upjohn Company. Following the Upjohn-Pharmacia merger, he joined the Center for Drug Development Science at Georgetown University as an Adjunct Professor of Pharmacology. From 1975 to 1979, Dr. Atkinson served as a member of the Pharmacology/Toxicology Program Committee of the National Institute of General Medical Sciences (NIGMS), and from 1984 to 1986, chaired the Pharmacological Sciences Program Committee for that institute. In 1997, he returned to NIH as a Special Expert Consultant in Clinical Pharmacology for NIGMS. The following year, he was appointed Senior Advisor in Clinical Pharmacology to the Director of the NIH Clinical Center where until October 2005 he directed the ClinPRAT postdoctoral training program and the Clinical Center course on Principles of Clinical Pharmacology. Dr. Atkinson is a Master of the American College of Physicians (MACP), and has been President of the Chicago Society of Internal Medicine, President of the American Board of Clinical Pharmacology, and President of the American Society for Clinical Pharmacology and Therapeutics. He currently is an Adjunct Professor in the Department of Pharmacology at the Feinberg Medical School of Northwestern University and serves as an Emeritus Associate Editor of Clinical Pharmacology and Therapeutics and Emeritus Editor of Translational and Clinical Pharmacology.
Department of Pharmacology, Feinberg Medical School, Northwestern University, Chicago, IL, USA
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