Principles of Clinical Pharmacology, 3rd Edition

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Principles of Clinical Pharmacology 3rd Edition eBook Free Download

Principles of Clinical Pharmacology 3rd Edition eBook PDF Free Download

Edited by Arthur J. Atkinson, Shiew-Mei Huang, Juan J.L. Lertora, Sanford P. Markey

Published by Academic Press

About the Book

This Principles of Clinical Pharmacology, 3rd Edition is edited by Arthur J. Atkinson, Shiew-Mei Huang, Juan J.L. Lertora, Sanford P. Markey. This Third Edition 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

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What You will Learn

The Topics Covered in this Textbook are

Introduction to Clinical Pharmacology
Additional Sources of Information
PI Pharmacokinetics
Clinical Pharmacokinetics
The Target Concentration Strategy
Concepts Underlying Clinical Pharmacokinetics
Mathematical Basis of Clinical Pharmacokinetics
Study Problems
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
Study Problems
Computer-Based Tutorials
Drug Absorption and Bioavailability
Drug Absorption
Kinetics of Drug Absorption After Oral Administration
Study Problems
Computer-Based Tutorials
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
Study Problem
Pharmacokinetics in Patients Requiring Renal Replacement Therapy
Kinetics of Intermittent Hemodialysis
Kinetics of Continuous and Sustained Renal Replacement Therapy
Clinical Considerations
Computer-Based Tutorial
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
Non-Compartmental and Compartmental Approaches to Pharmacokinetic Data Analysis
Kinetics, Pharmacokinetics and Pharmacokinetic Parameters
Non-Compartmental Analysis
Compartmental Analysis
Non-Compartmental vs Compartmental Models
Distributed Models of Drug Kinetics
Central Issues
Drug Modality I: Delivery Across a Planar-Tissue Interface
Drug Modality II: Delivery from a Point Source, Direct Interstitial Infusion
Population Pharmacokinetics
Analysis of Pharmacokinetic Data
Population Pharmacokinetics
Model Applications

P II Drug Metabolism and Transport
Pathways of Drug Metabolism
Phase I Biotransformations
Phase II Biotransformations (Conjugations)
Additional Effects on Drug Metabolism
Methods of Analysis of Drugs and Drug Metabolites
Choice of Analytical Methodology
Principles of Analysis
Examples of Current Assay Methods
Assay Selection
Clinical Pharmacogenetics
Hierarchy of Pharmacogenetic Information
Identification and Selection of Outliers in a Population
Examples of Important Genetic Polymorphisms
Conclusions and Future Directions
Mechanisms and Genetics of Drug Transport
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
Drug Interactions
Mechanisms of Drug Interactions
Predicting Drug Interactions and Product Labeling
Biochemical Mechanisms of Drug Toxicity
Drug-Induced Liver Toxicity
Immunologically Mediated Hepatotoxic Reactions
Mechanisms of Other Drug Toxicities
Pharmacogenomic Mechanisms of Drug Toxicity
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

P III Assessment of Drug Effects

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
Imaging in Drug Development
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
Dose–Effect and Concentration–Effect Analysis
Drug–Receptor Interactions
The Graded Dose–Effect Relationship
The Quantal Dose–Effect Relationship
Pharmacodynamic Models
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
Disease Progress Models
Clinical Pharmacology and Disease Progress
Disease Progress Models
Design of Trials to Study Disease Progress

P IV Optimizing and Evaluating Patient therapy
Pharmacological Differences between Men and Women
Effects of Extraneous Factors
Drug Therapy in Pregnant and Nursing Women
Pregnancy Physiology and its Effects on Pharmacokinetics
Pharmacokinetic Studies During Pregnancy
Placental Transfer of Drugs
Drug Therapy of Nursing Mothers
Pediatric Clinical Pharmacology and Therapeutics
Ontogeny of Pharmacokinetics in Children
Developmental Pharmacodynamics
Therapeutic Considerations
Application of Pediatric Pharmacology to Clinical Study Design
Drug Therapy in the Elderly
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
Clinical Analysis of Adverse Drug Reactions
Definitions and Classification
Assessing ADR Risk
Minimizing and Managing ADRS
Quality Assessment of Drug Therapy
Organizational Influences on Medication-Use Quality

PV Drug Discovery and Development
Portfolio and Project Planning and Management in the Drug Discovery, Evaluation, Development, and Regulatory Review Process
Portfolio Design, Planning, and Management
Project Planning and Management
Project Planning and Management Tools
Project Team Management and Decision-Making
Drug Discovery
Drug Discovery Philosophies and Definition of Drug Targets
Generating Diversity
Definition of Lead Structures
Qualifying Leads for Transition to Early Trials
Non-Clinical Drug Development
Components of Non-Clinical Drug Development
Translational Research in Oncology Drug Development
Preclinical Prediction of Human Pharmacokinetics
Physiologic Pharmacokinetics
Phase I Clinical Studies
Disease-Specific Considerations
Beyond Toxicity
Pharmacokinetic and Pharmacodynamic Considerations in the Development of Biotechnology Products and Large Molecules
Monoclonal Antibodies
Assay of Macromolecules
Interspecies Scaling of Macromolecules: Predictions in Humans
Pharmacokinetic Characteristics of Macromolecules
Pharmacodynamics of Macromolecules
Design of Clinical Development Programs
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
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

For Whom is this Book For



Format of the eBook: PDF      Size: 23.2 MB


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