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Author Daniels, Charles E
Title Principles of Clinical Pharmacology
Imprint Burlington : Elsevier Science & Technology, 2006
©2007
book jacket
Edition 2nd ed
Descript 1 online resource (567 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Note Front cover -- Title page -- Copyright page -- Table of contents -- Preface to the First Edition -- Preface to the Second Edition -- Contributors -- CHAPTER 1. Introduction to Clinical Pharmacology -- BACKGROUND -- PHARMACOKINETICS -- PART I: PHARMACOKINETICS -- CHAPTER 2. Clinical Pharmacokinetics -- THE TARGET CONCENTRATION STRATEGY -- CONCEPTS UNDERLYING CLINICAL PHARMACOKINETICS -- MATHEMATICAL BASIS OF CLINICAL PHARMACOKINETICS -- CHAPTER 3. Compartmental Analysis of Drug Distribution -- PHYSIOLOGICAL SIGNIFICANCE OF DRUG DISTRIBUTION VOLUMES -- PHYSIOLOGICAL BASIS OF MULTICOMPARTMENTAL MODELS OF DRUG DISTRIBUTION -- CLINICAL CONSEQUENCES OF DIFFERENT DRUG DISTRIBUTION PATTERNS -- ANALYSIS OF EXPERIMENTAL DATA -- CHAPTER 4. Drug Absorption and Bioavailability -- DRUG ABSORPTION -- BIOAVAILABILITY -- KINETICS OF DRUG ABSORPTION AFTER ORAL ADMINISTRATION -- CHAPTER 5. Effects of Renal Disease on Pharmacokinetics -- EFFECTS OF RENAL DISEASE ON DRUG ELIMINATION -- EFFECTS OF RENAL DISEASE ON DRUG DISTRIBUTION -- EFFECTS OF RENAL DISEASE ON DRUG ABSORPTION -- CHAPTER 6. Pharmacokinetics in Patients Requiring Renal Replacement Therapy -- KINETICS OF INTERMITTENT HEMODIALYSIS -- KINETICS OF CONTINUOUS RENAL REPLACEMENT THERAPY -- CLINICAL CONSIDERATIONS -- CHAPTER 7. Effect of Liver Disease on Pharmacokinetics -- HEPATIC ELIMINATION OF DRUGS -- EFFECTS OF LIVER DISEASE ON PHARMACOKINETICS -- USE OF THERAPEUTIC DRUGS IN PATIENTS WITH LIVER DISEASE -- CHAPTER 8. Noncompartmental versus Compartmental Approaches to Pharmacokinetic Analysis -- INTRODUCTION -- KINETICS, PHARMACOKINETICS, AND PHARMACOKINETIC PARAMETERS -- NONCOMPARTMENTAL ANALYSIS -- COMPARTMENTAL ANALYSIS -- NONCOMPARTMENTAL VERSUS COMPARTMENTAL MODELS -- CONCLUSION -- CHAPTER 9. Distributed Models of Drug Kinetics -- INTRODUCTION -- CENTRAL ISSUES
DRUG MODALITY I: DELIVERY ACROSS A PLANAR - TISSUE INTERFACE -- DRUG MODALITY II: DELIVERY FROM A POINT SOURCE - DIRECT INTERSTITIAL INFUSION -- SUMMARY -- CHAPTER 10. Population Pharmacokinetics -- INTRODUCTION -- ANALYSIS OF PHARMACOKINETIC DATA -- POPULATION PHARMACOKINETICS -- MODEL APPLICATIONS -- CONCLUSIONS -- PART II: DRUG METABOLISM AND TRANSPORT -- CHAPTER 11. Pathways of Drug Metabolism -- INTRODUCTION -- PHASE I BIOTRANSFORMATIONS -- PHASE II BIOTRANSFORMATIONS (CONJUGATIONS) -- ADDITIONAL EFFECTS ON DRUG METABOLISM -- CHAPTER 12. Methods of Analysis of Drugs and Drug Metabolites -- INTRODUCTION -- CHOICE OF ANALYTICAL METHODOLOGY -- CHROMATOGRAPHIC SEPARATIONS -- ABSORPTION AND EMISSION SPECTROSCOPY -- IMMUNOAFFINITY ASSAYS -- MASS SPECTROMETRY -- EXAMPLES OF CURRENT ASSAY METHODS -- CHAPTER 13. Clinical Pharmacogenetics -- INTRODUCTION -- HIERARCHY OF PHARMACOGENETIC INFORMATION -- IDENTIFICATION AND SELECTION OF OUTLIERS IN A POPULATION -- EXAMPLES OF IMPORTANT GENETIC POLYMORPHISMS -- CONCLUSIONS AND FUTURE DIRECTIONS -- CHAPTER 14. Equilibrative and Concentrative Transport Mechanisms -- INTRODUCTION -- MECHANISMS OF TRANSPORT ACROSS BIOLOGICAL MEMBRANES -- DESCRIPTION OF SELECTED MEMBRANE PROTEIN TRANSPORTERS -- ROLE OF TRANSPORTERS IN PHARMACOKINETICS AND DRUG ACTION -- PHARMACOGENETICS AND PHARMACOGENOMICS OF TRANSPORTERS -- FUTURE DIRECTIONS -- CHAPTER 15. Drug Interactions -- INTRODUCTION -- MECHANISMS OF DRUG INTERACTIONS -- PREDICTION AND CLINICAL MANAGEMENT OF DRUG INTERACTIONS -- CHAPTER 16. Biochemical Mechanisms of Drug Toxicity -- INTRODUCTION -- DRUG-INDUCED LIVER TOXICITY -- MECHANISMS OF OTHER DRUG TOXICITIES -- PART III: ASSESSMENT OF DRUG EFFECTS -- CHAPTER 17. Physiological and Laboratory Markers of Drug Effect -- BIOLOGICAL MARKERS OF DRUG EFFECT -- IDENTIFICATION AND EVALUATION OF BIOMARKERS
USES OF BIOMARKERS AND SURROGATE ENDPOINTS -- FUTURE DEVELOPMENT OF BIOMARKERS -- CHAPTER 18. Dose-Effect and Concentration-Effect Analysis -- BACKGROUND -- DRUG-RECEPTOR INTERACTIONS -- GRADED DOSE-EFFECT RELATIONSHIP -- QUANTAL DOSE-EFFECT RELATIONSHIP -- PHARMACODYNAMIC MODELS -- CONCLUSION -- CHAPTER 19. Time Course of Drug Response -- PHARMACOKINETICS AND DELAYED PHARMACOLOGIC EFFECTS -- PHYSIOKINETICS - TIME COURSE OF EFFECTS DUE TO PHYSIOLOGICAL TURNOVER PROCESSES -- THERAPEUTIC RESPONSE, CUMULATIVE DRUG EFFECTS, AND SCHEDULE DEPENDENCE -- CHAPTER 20. Disease Progress Models -- CLINICAL PHARMACOLOGY AND DISEASE PROGRESS -- DISEASE PROGRESS MODELS -- CONCLUSION -- PART IV: OPTIMIZING AND EVALUATING PATIENT THERAPHY -- CHAPTER 21. Pharmacological Differences between Men and Women -- PHARMACOKINETICS -- PHARMACODYNAMICS -- SUMMARY -- CHAPTER 22. Drug Therapy in Pregnant and Nursing Women -- PREGNANCY PHYSIOLOGY AND ITS EFFECTS ON PHARMACOKINETICS -- PHARMACOKINETIC STUDIES DURING PREGNANCY -- PLACENTAL TRANSFER OF DRUGS -- TERATOGENESIS -- DRUG THERAPY IN NURSING MOTHERS -- CHAPTER 23. Drug Therapy in Neonates and Pediatric Patients -- BACKGROUND -- ONTOGENY AND PHARMACOLOGY -- THERAPEUTIC IMPLICATIONS OF GROWTH AND DEVELOPMENT -- CONCLUSIONS -- CHAPTER 24. Drug Therapy in the Elderly -- INTRODUCTION -- PATHOPHYSIOLOGY OF AGING -- AGE-RELATED CHANGES IN PHARMACOKINETICS -- AGE-RELATED CHANGES IN EFFECTOR SYSTEM FUNCTION -- DRUG GROUPS FOR WHICH AGE CONFERS INCREASED RISK FOR TOXICITY -- CONCLUSIONS -- CHAPTER 25. Clinical Analysis of Adverse Drug Reactions -- INTRODUCTION -- CLASSIFICATION -- CLINICAL DETECTION -- ADR DETECTION IN CLINICAL TRIALS -- INFORMATION SOURCES -- CHAPTER 26. Quality Assessment of Drug Therapy -- INTRODUCTION -- ORGANIZATIONAL INFLUENCES ON MEDICATION USE QUALITY -- SUMMARY -- PART V: DRUG DISCOVERY AND DEVELOPMENT
CHAPTER 27. Portfolio and Project Planning and Management in the Drug Discovery, Development, and Review Process -- INTRODUCTION -- PORTFOLIO DESIGN, PLANNING, AND MANAGEMENT -- PROJECT PLANNING AND MANAGEMENT -- PROJECT PLANNING AND MANAGEMENT TOOLS -- PROJECT TEAM MANAGEMENT AND DECISION-MAKING -- CHAPTER 28. Drug Discovery -- INTRODUCTION -- DEFINITION OF DRUG TARGETS -- GENERATING DIVERSITY -- DEFINITION OF LEAD STRUCTURES -- QUALIFYING LEADS FOR TRANSITION TO EARLY TRIALS -- CHAPTER 29. Preclinical Drug Development -- INTRODUCTION -- COMPONENTS OF PRECLINICAL DRUG DEVELOPMENT -- DRUG DEVELOPMENT PROGRAMS AT THE NCI -- THE CHALLENGE - MOLECULARLY TARGETED THERAPIES AND NEW PARADIGMS FOR CLINICAL TRIALS -- CHAPTER 30. Animal Scale-Up -- INTRODUCTION -- ALLOMETRY -- PHYSIOLOGICAL PHARMACOKINETICS -- IN VITRO-IN VIVO CORRELATION OF HEPATIC METABOLISM -- CHAPTER 31. Phase I Clinical Studies -- INTRODUCTION -- DISEASE-SPECIFIC CONSIDERATIONS -- STARTING DOSE AND DOSE ESCALATION -- BEYOND TOXICITY -- CHAPTER 32. Development of Biotechnology Products and Large Molecules -- INTRODUCTION -- PHARMACOKINETIC CHARACTERISTICS OF MACROMOLECULES -- PHARMACODYNAMICS -- CHAPTER 33. Design of Clinical Development Programs -- INTRODUCTION -- PHASES, SIZE, AND SCOPE OF CLINICAL DEVELOPMENT PROGRAMS -- GOAL AND OBJECTIVES OF CLINICAL DRUG DEVELOPMENT -- CRITICAL DRUG DEVELOPMENT PARADIGMS -- CRITICAL CLINICAL DRUG DEVELOPMENT DECISION POINTS -- LEARNING CONTEMPORARY CLINICAL DRUG DEVELOPMENT -- CHAPTER 34. Role of the FDA in Guiding Drug Development -- WHY DOES THE FDA GET INVOLVED IN DRUG DEVELOPMENT? -- WHEN DOES THE FDA GET INVOLVED IN DRUG DEVELOPMENT? -- HOW DOES THE FDA GUIDE DRUG DEVELOPMENT? -- WHAT ARE FDA GUIDANCES? -- APPENDIX I. Abbreviated Tables of Laplace Transforms -- APPENDIX II. Answers to Study Problems -- Index
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. * 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
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
Link Print version: Daniels, Charles E. Principles of Clinical Pharmacology Burlington : Elsevier Science & Technology,c2006 9780123694171
Subject Clinical pharmacology
Electronic books
Alt Author Dedrick, Robert
Markey, Sanford P
Atkinson, Jr., Arthur J
Abernethy, Darrell R
Dedrick, Robert
Markey, Sanford P
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