Principles of Clinical Pharmacology

Principles of Clinical Pharmacology

2nd Edition - September 20, 2006

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  • Editors: Arthur Atkinson, Jr., Darrell Abernethy, Charles Daniels, Robert Dedrick, Sanford Markey
  • eBook ISBN: 9780080466422

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Description

This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered by the American Board of Clinical Pharmacology. This unique reference is recommended by the Board as a study text and includes modules on drug discovery and development to assist students as well as practicing pharmacologists.

Key Features

  • Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy
  • Unusual cohesive of presentation that stems from author participation in an ongoing popular NIH course
  • Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study
  • Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry
  • Expanded coverage of pharmacogenetics
  • Expanded coverage of drug transporters and their role in interactions
  • Inclusion of new material on enzyme induction mechanisms in chapters on drug metabolism and drug interactions
  • A new chapter on drug discovery that focuses on oncologic agents
  • Inclusion of therapeutic antibodies in chapter on biotechnology products

Readership

Clinical pharmacologists, pharmacologists, clinicians, pharmaceutical industry and government regulatory agencies

Table of Contents

  • 1. Introduction

    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
    15. Pharmacogenetics
    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

    Appendix
    I. Table of Laplace Transforms
    II. Answers to Study Problems

Product details

  • No. of pages: 568
  • Language: English
  • Copyright: © Academic Press 2006
  • Published: September 20, 2006
  • Imprint: Academic Press
  • eBook ISBN: 9780080466422

About the Editors

Arthur Atkinson, Jr.

Arthur Atkinson, Jr.
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.

Affiliations and Expertise

Department of Pharmacology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States

Darrell Abernethy

Affiliations and Expertise

National Institute on Aging, Baltimore, Maryland, U.S.A.

Charles Daniels

Affiliations and Expertise

Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA

Robert Dedrick

Affiliations and Expertise

National Institute of Health, Bethesda, Maryland, U.S.A.

Sanford Markey

Affiliations and Expertise

National Institute of Mental Health, Bethesda, Maryland, U.S.A.

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