Principles of Clinical
Pharmacology
October 2001; 18.350 Ptas. / 110,29 €;
600 Pag.
Edited by
Arthur Atkinson, Warren G.
Magnuson Clinical Center, Bethesda, Maryland,
U.S.A.
Charles Daniels, NIH Clinical
Center, Maryland, USA
Robert Dedrick, NIH Clinical
Center, Maryland, USA
Charles Grudzinskas, NIH
Clinical Center, Maryland, USA
Sanford P. Markey, National
Institute of Mental Health and NIH Clinical Center, Maryland, USA
The application of
pharmacokinetic principles, coupled with measurement of drug concentrations in
patient plasma, has vastly improved the efficacy and safety of therapy with a
number of clinically important drugs. For these reasons, the principles of
clinical pharmacology that are covered in this book are of fundamental
importance both to patient therapy and to the discovery and development of new
drugs.
The rate of introduction of new
pharmaceutical products has increased rapidly over the past decade, and details
learned about a particular drug become obsolete as it is replaced by newer
agents. Principles of Clinical Pharmacology focuses on the fundamentals
that underly the clinical use and contemporary development of pharmaceuticals.
The coverage of these principles in this book is of particular benefit to
individuals engaged either in the teaching or study of sound therapeutic
technique or in the investigation of pharmacological agents.
Features
- Breadth enables readers to
grasp applicability of clinical pharmacology principles to both clinical
practice and drug development.
- Cohesiveness of coverage
benefits the reader by reducing redundancy and allowing material in later
chapters to build on concepts presented earlier.
- Examples demonstrate the
central role of pharmacokinetic principles in both clinical practice and
drug development.
Contents
Introduction
PART 1: PHARMACOKINETICS:
Clinical pharmacokinetics.
Compartmental analysis of drug
distribution.
Drug absorption and
bioavailability.
Effects of renal disease on
pharmacokinetics.
Kinetics of hemodialysis and
hemofiltration.
Effects of liver disease on
pharmacokinetics.
Noncompartmental vs.
compartmental approaches to pharmacokinetic analysis.
Distributed models of drug
kinetics.
Population pharmacokinetics.
PART 2: DRUG METABOLISM AND
TRANSPORT:
Pathways of drug metabolism.
Chemical assay of drugs and
drug metabolites.
Pharmacogenetics.
Drug interactions.
Biochemical mechanisms of drug
toxicity.
Equilibrative and
concentrative transport.
PART 3: ASSESSMENT OF DRUG
EFFECTS:
Physiological and laboratory
markers of drug effect.
Dose response and
concentration response analysis.
Kinetics of pharmacologic
effect.
Disease progression models.
PART 4: OPTIMIZING AND
EVALUATING DRUG THERAPY:
Sex differences in
pharmacokinetics and pharmacodynamics.
Drug therapy in pregnant and
nursing women.
Drug therapy in neonates and
pediatric patients.
Drug therapy in the elderly.
Clinical analysis of adverse
drug reactions.
Quality assessment of drug
therapy.
PART 5: DRUG DISCOVERY AND
DEVELOPMENT:
Project management.
Drug discovery.
Pre-clinical development.
Animal scale up.
Phase I studies.
PK and PD considerations in
the development of biotechnology products and large molecules.
Design of clinical development
programs.
Role of the FDA in guiding
drug development.
Appendix I: Table of Laplace
Transforms
Appendix II: Answers to Study
Problems