Shargel and Yu Applied Biopharmaceutics and Pharmacokinetics 8th Edition by Andrew Yu, Murray Ducharme, Leon Shargel ISBN 9781260143003 1260143007

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ISBN 10: 1260143007
ISBN 13: 9781260143003
Author: Andrew Yu, Murray Ducharme, Leon Shargel

Shargel and Yu Applied Biopharmaceutics and Pharmacokinetics 8th Edition Table of contents:

PART I. Introduction to Biopharmaceutics and Pharmacokinetics

Chapter 1. Introduction to Biopharmaceutics and Pharmacokinetics

Drug Product Performance

Biopharmaceutics

Pharmacokinetics

Pharmacodynamics

Clinical Pharmacokinetics

Drug Exposure and Drug Response

Toxicokinetics and Clinical Toxicology

Measurement of Drug Concentrations

Pharmacokinetic Models

Computers in Pharmacokinetics

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 2. Mathematical Fundamentals in Pharmacokinetics

Calculus

Graphs

Practice Problem

Mathematical Expressions and Units

Units for Expressing Blood Concentrations

Measurement and Use of Significant Figures

Practice Problem

Practice Problem

Rates and Orders of Processes

Chapter Summary

Learning Questions

Answers

References

Chapter 3. Biostatistics

Variables

Types of Data (Nonparametric Versus Parametric)

Distributions

Measures of Central Tendency

Measures of Variability

Hypothesis Testing

Statistically Versus Clinically Significant Differences

Clinical Case

Statistical Inference Techniques in Hypothesis Testing for Parametric Data

Goodness of Fit

Statistical Inference Techniques for Hypothesis Testing with Nonparametric Data

Controlled Versus Uncontrolled Studies

Blinding

Confounding

Validity

Bioequivalence Studies

Evaluation of Risk for Clinical Studies

Chapter Summary

Learning Questions

Answers

References

PART II. Fundamentals of Biopharmaceutics

Chapter 4. Physiologic Factors Related to Drug Absorption

Drug Absorption and Design of a Drug Product

Route of Drug Administration

Nature of Cell Membranes

Passage of Drugs across Cell Membranes

Drug Interactions in the Gastrointestinal Tract

Oral Drug Absorption

Oral Drug Absorption during Drug Product Development

Methods for Studying Factors That Affect Drug Absorption

Effect of Disease States on Drug Absorption

Miscellaneous Routes of Drug Administration

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 5. Drug Distribution and Protein Binding

Introduction

How Does a Drug Interact with the Various Constituents in Blood?

How Does Drug Move from Blood into Tissues?

What Determines the Rate and Extent of Drug Distribution into Various Tissues?

How Do Membrane Transporters Influence Drug Distribution?

Do Drugs Distribute into Breast Milk?

Practice Problem

How Is the Extent of Drug Distribution in the Body Measured?

What Is the Effect of Plasma Protein Binding and Tissue Binding on Drug Distribution?

Practice Problem

How Is the Extent of Drug−Protein Binding Measured?

Practice Problem

How Are the Kinetics of Drug−Protein Binding Measured?

Practice Problems

How Are Binding Constants and Binding Sites Determined Experimentally?

What Are the Primary Plasma Proteins to Which Drugs Bind?

How Do Drug−Drug Protein Binding Interactions Influence Drug Distribution and Effect?

Chapter Summary

References

Chapter 6. Physiology of Drug Elimination

Introduction

Anatomy and Physiology of the Liver

Hepatic Enzymes Involved in the Biotransformation of Drugs

Drug Biotransformation Reactions

Pathways of Drug Biotransformation

Drug Interaction Example

Clinical Example

First-Pass Effects

Biliary Excretion of Drugs

Clinical Example

Role of Transporters in the Elimination of Drugs from the Liver

The Kidney and Renal Elimination

Practice Problems

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 7. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance

Introduction

Biopharmaceutic Factors and Rationale for Drug Product Design

Rate-Limiting Steps in Drug Absorption

Physicochemical Properties of the Drug

Influence of Excipients on Drug Product Performance

Evaluation of Drug Product Performance

Considerations in the Design and Performance of Drug Products

Examples Related to the Design and Perfomance of Drug Products

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 8. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Drug Product Performance

Purpose of Bioavailability and Bioequivalence Studies

Relative and Absolute Availability

Practice Problem

Methods for Assessing Bioavailability and Bioequivalence

In Vivo Measurement of Active Moiety or Moieties in Biological Fluids

Bioequivalence Studies Based on Pharmacodynamic Endpoints—In Vivo Pharmacodynamic Comparison

Bioequivalence Studies Based on Clinical Endpoints—Clinical Endpoint Study

In Vitro Studies

Other Approaches Deemed Acceptable (by the FDA)

Bioequivalence Studies Based on Multiple Endpoints

Bioequivalence Studies

Design and Evaluation of Bioequivalence Studies

Study Designs

Crossover Study Designs

Clinical Example

Clinical Example

Systemic Drug Exposure and Pharmacokinetic Evaluation of the Data

The Partial AUC in Bioequivalence Analysis

Bioequivalence Examples

Study Submission and Drug Review Process

Bioequivalence for Specific Drugs and Drug Products

Waivers of In Vivo Bioequivalence Studies (Biowaivers)

The Biopharmaceutics Classification System

Generic Biologics (Biosimilar Drug Products)

Clinical Significance of Bioequivalence Studies

Special Concerns in Bioavailability and Bioequivalence Studies

Chapter Summary

Learning Questions

Answers

References

Chapter 9. Modified-Release Drug Products and Drug Devices

Modified-Release Drug Products and Conventional (Immediate-Release) Drug Products

Biopharmaceutic Factors

Dosage Form Selection

Advantages and Disadvantages of Extended-Release Products

Kinetics of Extended-Release Dosage Forms

Pharmacokinetic Simulation of Extended-Release Products

Clinical Examples

Types of Extended-Release Products

Considerations in the Evaluation of Modified-Release Products

Evaluation of Modified-Release Products

Evaluation of In Vivo Bioavailability Data

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 10. Targeted Drug Delivery Systems and Biotechnology Products

Introduction

Biotechnology

Drug Carriers and Targeting

Targeted Drug Delivery

Pharmacokinetics of Biopharmaceuticals

Chapter Summary

References

PART III. Pharmacokinetic Principles

Chapter 11. Introduction to Pharmacokinetic and Pharmacodynamic Models and Analyses

Introduction

The Different Methods for Calculating PK/PD

Compartment Models

Noncompartmental Model

Physiologically-Based Pharmacokinetic Model

Pharmacokinetic/Pharmacodynamic (PK/PD) Model

Chapter Summary

References

Chapter 12. One-Compartment Open Model: Intravenous Bolus Administration

Introduction

Calculations of Pharmacokinetic Parameters

Clinical Utility of the One-Compartment Model

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 13. Multicompartment Models: Intravenous Bolus Administration

Two-Compartment Open Model

Clinical Application

Practice Problem

Practical Focus

Practice Problem

Practical Focus

Three-Compartment Open Model

Clinical Application

Clinical Application

Determination of Compartment Models

Practical Focus

Clinical Application

Clinical Example

Practical Problem

Clinical Application

Practical Application

Clinical Application

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 14. Intravenous Infusion

Introduction

One-Compartment Model Drugs

Infusion Method for Calculating Patient Elimination Half-Life

Loading Dose Plus IV Infusion—One-Compartment Model

Practice Problems

Estimation of Drug Clearance and VD from Infusion Data

Intravenous Infusion of Two-Compartment Model Drugs

Practical Focus

Chapter Summary

Learning Questions

Answers

Bibliography

Chapter 15. Pharmacokinetic Calculations for Drug Elimination and Clearance

Drug Elimination

Clinical Importance of Drug Clearance

Practice Problem

Principles of Clearance Calculations

Clearance Models

The Compartmental Approach

Relationship between Rate Constants, Volumes of Distribution and Clearances

The Noncompartmental Approach

Practice Problem

Practice Problem

Integration of Compartmental and Noncompartmental Approaches

The Physiologic Approach Using the “Well-Stirred Model” for Liver (and Other Organs) Clearance

Clearance Predictions Based on the Fractions Eliminated through the Kidney and Liver

Practice Problem

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 16. Pharmacokinetics of Drug Absorption

Introduction

Relationship between Absorption and Elimination Processes Following Oral Drug Administration

Drug Absorption Processes—General Concepts

Zero-Order Drug Absorption

Clinical Application—Transdermal Drug Delivery

First-Order Drug Absorption

Equations Describing Concentration−Time Profiles Following Drug Absorption

Clinical Application

Practice Problem

Methods for Calculating Pharmacokinetic Parameters Describing Drug Absorption

Practice Problem

Relationship between Absorption Rate and Bioavailability Parameters (AUC, Cmax, Tmax)

Chapter Summary

Learning Questions

Answers

References

Bibliography

Appendix A

Appendix B

Chapter 17. Multiple-Dosage Regimens

Drug Accumulation

Clinical Example

Repetitive Intravenous Injections

Intermittent Intravenous Infusion

Clinical Example

Estimation of K and VD of Aminoglycosides in Clinical Situations

Multiple-Oral-Dose Regimen

Loading Dose

Dosage Regimen Schedules

Clinical Example

Practice Problems

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 18. Nonlinear Pharmacokinetics

Saturable Enzyme Elimination Processes

Practice Problem

Practice Problem

Drug Elimination by Capacity-Limited Pharmacokinetics: One-Compartment Model, IV Bolus Injection

Practice Problems

Clinical Focus

Drugs Distributed as One-Compartment Model and Eliminated by Nonlinear Pharmacokinetics

Clinical Focus

Chronopharmacokinetics and Time-Dependent Pharmacokinetics

Clinical Focus

Bioavailability of Drugs That Follow Nonlinear Pharmacokinetics

Nonlinear Pharmacokinetics Due to Drug–Protein Binding

Dose-Dependent Pharmacokinetics

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 19. Empirical Models, Mechanistic Models, Statistical Moments, and Noncompartmental PK/PD Analyses

Noncompartmental Analysis

Model Development Considerations

Empirical Models

Mechanistic Models

Comparison of Different Approaches

Selection of Pharmacokinetic Models

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 20. Applications of Software Packages in Pharmacokinetics

Introduction

Software Applications

Overview of the Different Approaches in Software Packages

Software Packages

Chapter Summary

Learning Questions

Answers

References

Bibliography

PART IV. Pharmacodynamics and Clinical Pharmacokinetics

Chapter 21. Pharmacogenetics, Drug Metabolism, Transporters, and Individualization of Drug Therapy

Genetic Polymorphisms

Phase II Enzymes

Transporters

Glossary

Chapter Summary

Answers

References

Chapter 22. Relationship between Pharmacokinetics and Pharmacodynamics

Pharmacokinetics and Pharmacodynamics

Relationship of Dose to Pharmacologic Response

Relationship between Dose and Duration of Activity (teff), Single IV Bolus Injection

Practice Problem

Effect of Both Dose and Elimination Half-Life on the Duration of Activity

Effect of Elimination Half-Life on Duration of Activity

Substance Abuse Potential

Drug Tolerance and Physical Dependency

Hypersensitivity and Adverse Response

Biological Markers (Biomarkers)

Types of Pharmacodynamic Response

Chapter Summary

Learning Questions

Answers

References

Chapter 23. Application of Pharmacokinetics to Clinical Situations

Medication Therapy Management

Individualization of Drug Dosage Regimens

Therapeutic Drug Monitoring

Clinical Example

Clinical Example

Design of Dosage Regimens

Conversion from Intravenous Infusion to Oral Dosing

Determination of Dose

Practice Problems

Effect of Changing Dose and Dosing Interval on Cmax(ss), Cmin(ss), and Cav(ss)

Determination of Frequency of Drug Administration

Determination of Both Dose and Dosage Interval

Practice Problem

Determination of Route of Administration

Dosing in Specific Populations

Pharmacokinetics of Drug Interactions

Inhibition of Drug Metabolism, Monoamine Oxidase (MAO), Drug Metabolism, Drug Absorption, and Biliary Excretion

Altered Renal Reabsorption due to Changing Urinary pH

Practical Focus

Effect of Food on Drug Disposition

Adverse Viral Drug Interactions

Population Pharmacokinetics

Clinical Example 1

Clinical Example 2

Practice Problem

Regional Pharmacokinetics

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 24. Application of Pharmacokinetics and Pharmacodynamics to Aging, Obese, and Pediatric Patients

Introduction

Application of Pharmacokinetics to Older Adults

Application of Pharmacokinetics to the Obese Patient

Application of Pharmacokinetics to Pediatric Patients

Learning Questions

Answers

References

Chapter 25. Dose Adjustment in Renal and Hepatic Diseases

Renal Impairment

Pharmacokinetic Considerations

General Approaches for Dose Adjustment in Renal Disease

Measurement of the Kidney’s Glomerular Filtration Rate

Serum Creatinine Concentration and Creatinine Clearance

Practice Problems

Dose Adjustment in Patients with Renal Impairment

Practice Problem

Practice Problem

Extracorporeal Removal of Drugs

Practice Problem

Clinical Example

Effect of Hepatic Disease on Pharmacokinetics

Practice Problem

Chapter Summary

Learning Questions

Answers

References

Bibliography

PART V. Biopharmaceutics and Pharmacokinetics in Drug Product Development

Chapter 26. Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence

Introduction

Pharmaceutical Alternatives

Practice Problem

Changes to an Approved NDA or ANDA

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

How Prevalent Is the Therapeutic Nonequivalence of a Generic Product?

The Future of Pharmaceutical Equivalence and Therapeutic Equivalence

Complex Drug Products

Biosimilar Drug Products

Historical Perspective

Chapter Summary

Learning Questions

Answers

References

Chapter 27. Rational Drug Product Development, Quality, and Performance

Risks from Medicines

Risk Assessment

Drug Product Quality and Drug Product Performance

Pharmaceutical Development

Excipient Effect on Drug Product Performance

Practical Focus

Quality Control and Quality Assurance

Practical Focus

Types of Quality Risk

Risk Management

Scale-Up and Postapproval Changes

Practical Focus

Product Quality Problems

Postmarketing Surveillance

Glossary

Chapter Summary

Learning Questions

Answers

References

Bibliography

Chapter 28. FDA-Approved Novel Dosage Forms

Introduction

Regulatory Pathway for New, Novel, and Drug–Device Combination Products

New and Novel Dosage Forms

Drug–Device Combination Products

Chapter Summary

Learning Questions

Answers

References

Chapter 29. Clinical Development and Therapeutic Equivalence of Generic Drugs and Biosimilar Products

Introduction

Bioequivalence

Interchangeability, Substitution, and Switchability Notions

Documentation Showing Establishment of Bioequivalence and Interchangeability of Generic Products

Approval of Generic Products

Filing of Generic Submissions in the United States, Canada, and the European Union

The Different “Generic” Terms

Regulatory Requirements for Generic Submissions in the United States, Canada, and Europe

Clinical Pharmacology Basis Linking PK Equivalence Studies with Presumed Equivalent Safety and Efficacy

Statistical Evaluation of Bioequivalence Metrics

PK Equivalence Clinical Study Requirements for FDA, HC, and EMA

Equivalence Requirements for Products That Are Not Intended to Act Via the Systemic Circulation (“Locally Acting”)

Equivalence Requirements for Biological Products (“Biosimilars”)

Chapter Summary

Answers

References

Bibliography

Chapter 30. Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development

Introduction

Overview of the Drug Development Process

Overview of the Drug Submission Pathways in the United States, the European Union, and Canada

Essential PK/PD Knowledge for a New Drug Submission

Practical Problem

Practical Problems

Practical Problem

Practical Problem

Clinical Problem

Pre-Submission Scientific Meetings with Regulators

Phase IV Studies

Chapter Summary

References

Bibliography

Glossary

Index

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Tags: Andrew Yu, Murray Ducharme, Leon Shargel, Applied Biopharmaceutics, Pharmacokinetics