Principles of Clinical Pharmacology

Author:   Shiew-Mei Huang (Acting Director, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation Research (CDER), Food and Drug Administration (FDA) in Silver Spring, MD, USA) ,  Juan J.L. Lertora (Adjunct Professor, Department of Medicine, Duke University, Durham, NC, USA) ,  Arthur J. Atkinson, Jr. (Department of Pharmacology, Feinberg Medical School, Northwestern University, Chicago, IL, USA) ,  Sanford P. Markey (National Institute of Mental Health, Bethesda, Maryland, U.S.A.)
Publisher:   Elsevier Science Publishing Co Inc
Edition:   3rd edition
ISBN:  

9780123854711


Pages:   652
Publication Date:   10 November 2012
Replaced By:   9780128198698
Format:   Hardback
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

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Principles of Clinical Pharmacology


Overview

Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference 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 third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science. The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics

Full Product Details

Author:   Shiew-Mei Huang (Acting Director, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation Research (CDER), Food and Drug Administration (FDA) in Silver Spring, MD, USA) ,  Juan J.L. Lertora (Adjunct Professor, Department of Medicine, Duke University, Durham, NC, USA) ,  Arthur J. Atkinson, Jr. (Department of Pharmacology, Feinberg Medical School, Northwestern University, Chicago, IL, USA) ,  Sanford P. Markey (National Institute of Mental Health, Bethesda, Maryland, U.S.A.)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Edition:   3rd edition
Dimensions:   Width: 21.60cm , Height: 3.60cm , Length: 27.60cm
Weight:   1.980kg
ISBN:  

9780123854711


ISBN 10:   0123854717
Pages:   652
Publication Date:   10 November 2012
Audience:   Professional and scholarly ,  Professional & Vocational
Replaced By:   9780128198698
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

Table of Contents

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

Reviews

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)


Author Information

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. 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. 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.

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