Principles of clinical pharmacology (3rd edition - 2012)

Atkinson, Arthur Jr. (editor of compilation)

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Principles of clinical pharmacology (3rd edition - 2012)

Atkinson, Arthur Jr. (editor of compilation)

URI: http://10.250.8.41:8080/xmlui/handle/123456789/47377

Date: 2012

Abstract:

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.* Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions. * Offers an expanded regulatory section that addresses US and international issues and guidelines. * Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response. * Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III.

Description:

xxi, 626 pages: illustrations; 29 cm || Includes bibliographical references. || CONTENTS: Preface to the First Edition -- Contributors -- Chapter 1. Introduction to Clinical -- Pharmacology -- Background -- Pharmacokinetics -- References -- Additional Sources of Information -- Part I: Pharmacokinetics -- Chapter 2. Clinical Pharmacokinetics -- The Target Concentration Strategy -- Concepts Underlying Clinical Pharmacokinetics -- Mathematical Basis of Clinical Pharmacokinetics -- References -- Study Problems -- Chapter 3. Compartmental Analysis of Drug Distribution -- Fit-for-Purpose Modeling of Drug Distribution -- Physiological Significance of Drug Distribution Volumes -- Physiological Basis of Multicompartmental Models of Drug Distribution -- Clinical Consequences of Different Drug Distribution Patterns -- Estimating Model Parameters from Experimental Data -- References -- Study Problems -- Computer-Based Tutorials -- Chapter 4. Drug Absorption and Bioavailability -- Drug Absorption -- Bioavailability -- Kinetics of Drug Absorption After Oral Administration -- References -- Study Problems -- Computer-Based Tutorials -- Chapter 5. Effect of Renal Disease on Pharmacokinetics -- Drug Dosing in Patients with Impaired Renal Function -- Effects of Renal Disease on Renal Drug Excretion Mechanisms -- Effects of Impaired Renal Function on Non-Renal Metabolism -- Effects of Renal Disease on Drug Distribution -- Effects of Renal Disease on Drug Absorption -- References -- Study Problem -- Chapter 6. Pharmacokinetics in Patients Requiring Renal Replacement Therapy -- Kinetics of Intermittent Hemodialysis -- Kinetics of Continuous and Sustained Renal Replacement Therapy -- Clinical Considerations -- References -- Computer-Based Tutorial -- 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 -- References -- Chapter 8. Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data Analysis -- Introduction -- Kinetics, Pharmacokinetics and Pharmacokinetic Parameters -- Non-Compartmental Analysis -- Compartmental Analysis -- Non-Compartmental vs Compartmental Models -- Conclusion -- References -- 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 -- References -- Chapter 10. Population Pharmacokinetics -- Introduction -- Analysis of Pharmacokinetic Data -- Population Pharmacokinetics -- Model Applications -- Conclusions -- References -- 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 References -- Chapter 12. Methods of Analysis of Drugs and Drug Metabolites -- Introduction -- Choice of Analytical Methodology -- Principles of Analysis -- Examples of Current Assay Methods -- Assay Selection -- References -- 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 -- References -- Chapter 14. Mechanisms and Genetics of Drug Transport -- Introduction -- Mechanisms of Transport Across Biological Membranes Nomenclature, -- Genetic Classification, and Function of Selected Membrane Transporters -- Role of Transporters in Pharmacokinetics and Drug Action Pharmacogenetics and Pharmacogenomics of Membrane Transport -- Conclusions and Future Perspectives -- References -- Chapter 15. Drug Interactions -- Introduction -- Mechanisms of Drug Interactions -- Predicting Drug Interactions and Product Labeling -- References -- Chapter 16. Biochemical Mechanisms of Drug Toxicity -- Introduction -- Drug-Induced Liver Toxicity -- Immunologically Mediated Hepatotoxic Reactions --Mechanisms of Other Drug Toxicities -- References -- Chapter 17. Pharmacogenomic Mechanisms of Drug Toxicity -- Introduction ADRs with a Pharmacogenomic -- Basis Genetic Mechanisms for Drug-Induced -- Hypersensitivity Reactions -- FDA Labeling of Drugs for Pharmacogenomic -- Information -- The Role of Simulation in Elucidating Pharmacogenomic ADR Mechanisms -- The Role of Consortia in Elucidating Pharmacogenomic ADR Mechanisms -- Acknowledgement -- References -- Part III: Assessment of Drug Effects Chapter -- 18. Physiological and Laboratory Markers of Drug Effect -- Conceptual Framework Identification and Evaluation of Biomarkers -- Uses of Biomarkers Case Study: Development and Use of Serum Cholesterol as a Biomarker and Surrogate Endpoint -- Future Development of Biomarkers -- References -- Chapter 19. Imaging in Drug Development Introduction The Case for Molecular Imaging Challenges to Using Imaging in Drug Development Molecular Imaging Technologies Imaging Biomarker Examples Imaging Biology and Predicting Response Imaging Therapeutic Drug Effects Conclusion References Chapter 20. Dose–Effect and Concentration–Effect Analysis Background Drug–Receptor Interactions The Graded Dose–Effect Relationship The Quantal Dose–Effect Relationship Pharmacodynamic Models Conclusion References Chapter 21. Time Course of Drug Response Pharmacokinetics and Delayed Pharmacologic Effects Physiokinetics – the Time Course of Effects Due to Physiological Turnover Processes Therapeutic Response, Cumulative Drug Effects, and Schedule Dependence References Chapter 22. Disease Progress Models Clinical Pharmacology and Disease Progress Disease Progress Models Design of Trials to Study Disease Progress Conclusion References Part IV: Optimizing and Evaluating Patient therapy Chapter 23. Pharmacological Differences between Men and Women Introduction Pharmacokinetics Pharmacodynamics Effects of Extraneous Factors Summary Acknowledgement References Chapter 24. 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 of Nursing Mothers References Chapter 25. Pediatric Clinical Pharmacology and Therapeutics Introduction Ontogeny of Pharmacokinetics in Children Developmental Pharmacodynamics Therapeutic Considerations Application of Pediatric Pharmacology to Clinical Study Design References Chapter 26. 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 References Chapter 27. Clinical Analysis of Adverse Drug Reactions Introduction Definitions and Classification Assessing ADR Risk Minimizing and Managing ADRS References Chapter 28. Quality Assessment of Drug Therapy Introduction Organizational Influences on Medication-Use Quality Summary References Part V: Drug Discovery and Development Chapter 29. Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process Introduction Portfolio Design, Planning, and Management Project Planning and Management Project Planning and Management Tools Project Team Management and Decision-Making References Chapter 30. Drug Discovery Introduction Drug Discovery Philosophies and Definition of Drug Targets Generating Diversity Definition of Lead Structures Qualifying Leads for Transition to Early Trials Acknowledgement References Chapter 31. Non-Clinical Drug Development Introduction Components of Non-Clinical Drug Development Translational Research in Oncology Drug Development References Chapter 32. Preclinical Prediction of Human Pharmacokinetics Introduction Allometry Microdosing Physiologic Pharmacokinetics References Chapter 33. Phase I Clinical Studies Introduction Disease-Specific Considerations Beyond Toxicity References Chapter 34. Pharmacokinetic and Pharmacodynamic Considerations in the Development of Biotechnology Products and Large Molecules Introduction Monoclonal Antibodies Assay of Macromolecules Interspecies Scaling of Macromolecules: Predictions in Humans Pharmacokinetic Characteristics of Macromolecules Pharmacodynamics of Macromolecules References Chapter 35. Design of Clinical Development Programs Introduction Principles of Clinical Development Legal and Regulatory Requirements Evidence-Based, Goal-Directed Clinical Development Specific Design Issues in Clinical Development Programs Conduct of Clinical Development Special Topics References Chapter 36. The 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? The Role of the FDA Office of Clinical Pharmacology Disclaimer References Appendix I. Abbreviated Tables of Laplace Transforms Appendix II. Answers to Study Problems Answers to Study Problems – Chapter 2 Answers To Study Problems – Chapter 3 Answers to Study Problems – Chapter 4 Answer To Study Problem – Chapter 5 Subject Index

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