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Principles of Clinical Pharmacology
 
 

Principles of Clinical Pharmacology, 3rd Edition

 
Principles of Clinical Pharmacology, 3rd Edition,Arthur Atkinson, Jr.,Shiew-Mei Huang,Juan Lertora,Sanford Markey,ISBN9780123854711
 
 
 

Atkinson, Jr.   &   Huang   &   Lertora   &   Markey   

Academic Press

9780123854711

9780123854728

656

276 X 216

A valuable resource covering the science of drug discovery and development as it relates to individual patient therapy.

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Key Features

* 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

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

Readership

Clinical pharmacologists, pharmacologists, clinicians and scientists working in the pharmaceutical industry and government regulatory agencies

Arthur Atkinson, Jr.

Affiliations and Expertise

Northwestern University, Chicago, Illinois , U.S.A.

Shiew-Mei Huang

Affiliations and Expertise

FDA, Silver Spring, Maryland, U.S.A.

Juan Lertora

Affiliations and Expertise

NIH Clinical Center, Bethesda, MD, U.S.A.

Sanford Markey

Affiliations and Expertise

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

Principles of Clinical Pharmacology, 3rd Edition

Preface to the First Edition

Preface to the Third 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

Quotes and reviews

"…this is an excellent textbook that provides a comprehensive overview of the fundamentals and state of the art of clinical pharmacology. It will be an invaluable reference source for many current and future scientists in the field."--Clinical Pharmacology & Therapeutics, June 2013
"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)

 
 
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