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Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

by: Shargel, Leon; Wu-Pong, Susanna; Yu, Andrew

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

by: Shargel, Leon; Wu-Pong, Susanna; Yu, Andrew

ISBN 13:
9780071375504
ISBN 10:
0071375503
Edition: 5th
Format: Hardcover
Copyright: 08/19/2004
Publisher: McGraw-Hill Medical
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Summary

The most comprehensive text on the practical applications of biopharmaceuticals and pharmacokinetics! The required text for the biopharmaceuticals and/or pharmacokinetics course sequence, this text emphasizes the application and understanding of concepts. Thoroughly revised, this edition continues to help students gain skills in problem solving and features examples, practice problems, and solutions.

Preface

Glossary

xvii

1. INTRODUCTION TO BIOPHARMACEUTICS AND PHARMACOKINETICS

(20)

Biopharmaceutics

(2)

Pharmacokinetics

(1)

Clinical Pharmacokinetics

(1)

Pharmcodynamics

(1)

Toxicokinetics and Clinical Toxicology

(1)

Measurement of Drug Concentrations

(4)

Basic Pharmacokinetics and Pharmacokinetic Models

(9)

References

(1)

Bibliography

(3)

2. MATHEMATIC FUNDAMENTALS IN PHARMACOKINETICS

(30)

Math Self-Exam

(1)

Estimation and the Use of Calculators and Computers

(5)

Calculus

(3)

Graphs

(7)

Units in Pharmacokinetics

(1)

Measurement and Use of Significant Figures

(1)

Units for Expressing Blood Concentrations

(1)

Statistics

(3)

Rates and Orders of Reactions

(5)

Frequently Asked Questions

(1)

Learning Questions

(2)

References

(1)

Bibliography

(1)

3. ONE-COMPARTMENT OPEN MODEL: INTRAVENOUS BOLUS ADMINISTRATION

(22)

Elimination Rate Constant

(1)

Apparent Volume of Distribution

(4)

Clearance

(6)

Calculation of K from Urinary Excretion Data

(6)

Frequently Asked Questions

(1)

Learning Questions

(3)

Reference

(1)

Bibliography

(1)

4. MULTICOMPARTMENTAL MODELS: INTRAVENOUS BOLUS ADMINISTRATION

(32)

Two-Compartment Open Model

(18)

Three-Compartment Open Model

(2)

Determination of Compartment Models

(6)

Frequently Asked Questions

101

(1)

Learning Questions

102

(3)

References

105

(1)

Bibliography

105

(1)

5. INTRAVENOUS INFUSION

105

(26)

One-Compartment Model Drugs

108

(4)

Infusion Method for Calculating Patient Elimination Half-Life

112

(3)

Loading Dose Plus IV Infusion: One-Compartment Model

115

(7)

Estimation of Drug Clearance and VD from Infusion Data

122

(1)

Intravenous Infusion of Two Compartment Model Drugs

122

(1)

Loading Dose Plus IV Infusion: Two-Compartment Model

123

(4)

Frequently Asked Questions

127

(1)

Learning Questions

127

(2)

Reference

129

(1)

Bibliography

129

(2)

6. DRUG ELIMINATION AND CLEARANCE

131

(30)

Drug Elimination

131

(1)

The Kidney

132

(4)

Renal Drug Excretion

136

(3)

Drug Clearance

139

(3)

Clearance Models

142

(2)

Renal Clearance

144

(5)

Determination of Renal Clearance

149

(6)

Relationship of Clearance to Elimination Half-Life and Volume of Distribution

155

(2)

Frequently Asked Questions

157

(1)

Learning Questions

158

(1)

References

159

(1)

Bibliography

159

(2)

7. PHARMACOKINETICS OF ORAL ABSORPTION

161

(24)

Pharmacokinetics of Drug Absorption

161

(2)

Zero-Order Absorption Model

163

(1)

First-Order Absorption Model

164

(17)

Significance of Absorption Rate Constants

181

(1)

Frequently Asked Questions

182

(1)

Learning Questions

182

(2)

References

184

(1)

Bibliography

184

(1)

8. MULTIPLE DOSAGE REGIMENS

185

(34)

Drug Accumulation

185

(5)

Repetitive Intravenous Injections

190

(7)

Intermittent Intravenous Infusion

197

(4)

Estimation of k and VD of Aminoglycosides in Clinical Situations

201

(1)

Multiple-Oral-Dose Regimen

202

(3)

Loading Dose

205

(2)

Determination of Bioavailability and Bioequivalance in a Multiple-Dose Regimen

207

(1)

Bioequivalence Studies

208

(2)

Dosage Regimen Schedules

210

(5)

Frequently Asked Questions

215

(1)

Learning Questions

215

(1)

References

216

(1)

Bibliography

217

(2)

9. NONLINEAR PHARMACOKINETICS

219

(32)

Saturable Enzymatic Elimination Processes

221

(3)

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

224

(15)

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

239

(4)

Bioavailability of Drugs That Follow Nonlinear Pharmacokinetics

243

(1)

Nonlinear Pharmacokinetics Due to Drug-Protein Binding

243

(3)

Frequently Asked Questions

246

(1)

Learning Questions

246

(2)

References

248

(1)

Bibliography

248

(3)

10. PHYSIOLOGIC DRUG DISTRIBUTION AND PROTEIN BINDING

251

(52)

Physiologic Factors of Distribution

251

(8)

Apparent Volume Distribution

259

(8)

Protein Binding of Drugs

267

(8)

Relationship of Plasma Drug-Protein Binding to Distribution and Elimination

275

(4)

Determinants of Protein Binding

279

(1)

Kinetics of Protein Binding

280

(2)

Determination of Binding Constants and Binding Sites by Graphic Methods

282

(4)

Clinical Significance of Drug-Protein Binding

286

(10)

Modeling Drug Distribution

296

(1)

Frequently Asked Questions

297

(1)

Learning Questions

298

(1)

References

299

(2)

Bibliography

301

(2)

11. HEPATIC ELIMINATION OF DRUGS

303

(52)

Route of Drug Administration and Extrahepatic Metabolism

303

(5)

Enzyme Kinetics

308

(8)

Anatomy and Physiology of the Liver

316

(3)

Hepatic Enzymes Involved in the Biotransformation of Drugs

319

(2)

Pathways of Drug Biotransformation

321

(11)

First-Pass Effects

332

(8)

Hepatic Clearance of a Protein-Bound Drug: Restrictive and Nonrestrictive Clearance from Binding

340

(4)

Biliary Excretion of Drugs

344

(4)

Frequently Asked Questions

348

(1)

Learning Questions

348

(3)

References

351

(2)

Bibliography

353

(2)

12. PHARMACOGENETICS

355

(16)

Example of Polymorphisms

356

(3)

Pharmacogenomics

359

(2)

Adverse Drug Reactions Attributed to Genetic Differences

361

(1)

Genetic Polymorphism in Drug Metabolism: Cytochrome P-450 Isozymes

361

(3)

Genetic Polymorphism in Drug Transport: P-Glycoprotein and Multidrug Resistance

364

(1)

Genetic Polymorphism in Drug Targets

365

(1)

Pharmacokinetics Pharmacodynamics (PK PD) Considerations and Pharmacogenetics Pharmacogenomics (PGt PGx)

366

(1)

Frequently Asked Questions

367

(1)

References

368

(1)

Bibliography

369

(2)

13. PHYSIOLOGIC FACTORS RELATED TO DRUG ABSORPTION

371

(40)

Route of Drug Administration

371

(2)

Nature of Cell Membranes

373

(2)

Passage of Drugs Across Cell Membranes

375

(7)

Oral Drug Asorption

382

(14)

Methods for Studying Factors That Affect Drug Absorption

396

(5)

Effect of Disease States on Drug Absorption

401

(4)

Frequently Asked Questions

405

(1)

Learning Questions

405

(1)

References

406

(2)

Bibliography

408

(3)

14. BIOPHARMACEUTIC CONSIDERATIONS IN DRUG PRODUCT DESIGN

411

(42)

Rate-Limiting Steps in Drug Absorption

413

(1)

Pharmaceutic Factors Affecting Drug Bioavailability

413

(2)

Physicochemical Nature of the Drug

415

(3)

Formulation Factors Affecting Drug Dissolution

418

(3)

Dissolution and Drug Release Testing

421

(3)

Compendial Methods of Dissolution

424

(4)

Meeting Dissolution Requirements

428

(1)

Alternative Methods of Dissolution Testing

429

(1)

Problems of Variable Control in Dissolution Testing

430

(1)

In-Vitro-In-Vivo Correlation

431

(5)

Biopharmaceutic Considerations

436

(1)

Pharmacodynamic Considerations

437

(1)

Drug Considerations

437

(1)

Drug Product Considerations

438

(1)

Patient Considerations

439

(1)

Route of Drug Administration

439

(10)

Frequently Asked Questions

449

(1)

Learning Questions

450

(1)

References

450

(1)

Bibliography

451

(2)

15. BIOAVAILABILITY AND BIOECTIVALENCE

453

(48)

Definitions

453

(3)

Purpose of Bioavailability Studies

456

(1)

Relative and Absolute Availability

457

(3)

Methods for Assessing Bioavailability

460

(5)

Bioequivalence Studies

465

(2)

Design and Evaluation of Bioequivalence Studies

467

(3)

Study Designs

470

(3)

Evaluation of the Data

473

(2)

Bioequivalence Example

475

(3)

Study Submission and Drug Review Process

478

(4)

The Biopharmaceutics Classification System (BCS)

482

(3)

Generic Biologics

485

(1)

Clinical Significance of Bioequivalence Studies

486

(1)

Special Concerns in Bioavailability and Bioequivalence Studies

487

(2)

Generic Substitution

489

(2)

Frequently Asked Questions

491

(1)

Learning Questions

492

(6)

References

498

(1)

Bibliography

498

(3)

16. IMPACT OF DRUG PRODUCT QUALITY AND BIOPHARNIACEUTICS ON CLINICAL EFFICACY

501

(14)

Risks from Medicines

501

(3)

Risk Management

504

(2)

Scale-Up and Postapproval Changes (SUPAC)

506

(5)

Product Quality Problems

511

(2)

Frequently Asked Questions

513

(1)

Learning Questions

513

(1)

References

514

(1)

17. MODIFIED-RELEASE DRUG PRODUCTS

515

(38)

Examples of Modified-Release Oral Dosage Forms

516

(2)

Biopharmaceutic Factors

518

(3)

Dosage Form Selection

521

(1)

Advantages and Disadvantages of Extended-Release Products

521

(2)

Kinetics of Extended-Release Dosage Forms

523

(2)

Pharmacokinetic Simulation of Extended-Release Products

525

(2)

Types of Extended-Release Products

527

(15)

Considerations in the Evaluation of Modified-Release Products

542

(5)

Evaluation of In-Vivo Bioavailability Data

547

(2)

Frequently Asked Questions

549

(1)

Learning Questions

549

(1)

References

550

(1)

Bibliography

551

(2)

18. TARGETED DRUG DELIVERY SYSTEMS AND BIOTECHNOLOGICAL PRODUCTS

553

(22)

Biotechnology

554

(8)

Drug Carriers and Targeting

562

(5)

Targeted Drug Delivery

567

(2)

Pharmacokinetics of Biopharmaceuticals

569

(2)

Bioequivalence of Biotechnology-Derived Drug Products

571

(1)

Frequently Asked Questions

571

(1)

Learning Questions

572

(1)

References

572

(1)

Bibliography

573

(2)

19. RELATIONSHIP BETWEEN PHARMACOKINETICS AND PHARMACODYNAMICS

575

(38)

Pharmacodynamics and Pharmacokinetics

575

(2)

Relation of Dose to Pharmacologic Effect

577

(3)

Relationship between Dose and Duration of Activity (t3ff), Single Intravenous Bolus Injection

580

(2)

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

582

(1)

Effect of Elimination Half-Life on Duration of Activity

582

(5)

Rate of Drug Absorption and Pharmacodynamic Response

587

(1)

Drug Tolerance and Physical Dependency

588

(1)

Hypersensitivity and Adverse Response

589

(1)

Drug Distribution and Pharmacologic Response

590

(3)

Pharmacodynamic Models

593

(15)

Frequently Asked Questions

608

(1)

Learning Questions

608

(1)

References

609

(1)

Bibliography

610

(3)

20. APPLICATION OF PHARMACOKINETICS IN CLINICAL SITUATIONS

613

(60)

Individualization of Drug Dosage Regimens

613

(1)

Therapeutic Drug Monitoring

614

(9)

Design of Dosage Regimens

623

(1)

Conversion from Intravenous Infusion to Oral Dosing

624

(2)

Determination of Dose

626

(2)

Effect of Changing Dose and Dosing Interval on Cinfinity max, Cinfintiy min, and Cinfinity av

628

(1)

Determination of Frequency of Drug Administration

629

(1)

Determination of Both Dose and Dosage Interval

630

(1)

Nomograms and Tabulations in Designing Dosage Regimens

631

(2)

Determination of Route of Administration

633

(1)

Dosing of Drugs in Infants and Children

634

(2)

Dosing of Drugs in the Elderly

636

(4)

Dosing of Drugs in the Obese Patient

640

(2)

Pharmacokinetics of Drug Interactions

642

(3)

Inhibition of Drug Metabolism

645

(2)

Inhibition of Biliary Excretion

647

(1)

Induction of Drug Metabolism

648

(1)

Altered Renal Reabsorption Due to Changing Urinary pH

648

(1)

Inhibition of Drug Absorption

649

(1)

Effect of Food on Drug Disposition

649

(1)

Adverse Viral Drug Interactions

649

(1)

Population Pharmacokinetics

650

(14)

Regional Pharmacokinetics

664

(1)

Frequently Asked Questions

665

(1)

Learning Questions

665

(3)

References

668

(2)

Bibliography

670

(3)

21. DOSE ADJUSTMENT IN RENAL AND HEPATIC DISEASE

673

(44)

Renal Impairment

673

(1)

Pharmacokinetic Considerations

673

(2)

General Approaches for Dose Adjustment in Renal Disease

675

(2)

Measurement of Glomerular Filtration Rate

677

(1)

Serum Creatinine Concentration and Creatinine Clearance

678

(5)

Dose Adjustment for Uremic Patients

683

(13)

Extracorporeal Removal of Drugs

696

(9)

Effect of Hepatic Disease on Pharmacokinetics

705

(7)

Frequently Asked Questions

712

(1)

Learning Questions

713

(1)

References

714

(1)

Bibliography

715

(2)

22. PHYSIOLOGICAL PHARMACOKINETIC MODELS, MEAN RESIDENT TIME, AND STATISTICAL MOMENT THEORY

717

(40)

Physiologic Pharmacokinetic Models

718

(13)

Mean Residence Time

731

(5)

Statistical Moment Theory

736

(15)

Selection of Pharmacokinetic Models

751

(3)

Frequently Asked Questions

754

(1)

Learning Questions

754

(1)

References

755

(1)

Bibliography

756

(1)

Appendix A Statistics

757

(18)

Appendix B Applications of Computers in Pharmacokinetics

775

(16)

Appendix C Ethical Considerations

791

(66)

Appendix D Solutions to Frequently Asked Questions (FAQ) and Learning Questions

857

(6)

Appendix E Popular Drugs and Pharmacokinetic Parameters

863

(6)

Index

869

Amazon no longer offers textbook rentals. We do!

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

9780071375504

0071375503

Summary

Author Biography

Table of Contents

Supplemental Materials

Write a Review

Amazon no longer offers textbook rentals. We do!

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

9780071375504

0071375503

Summary

Author Biography

Table of Contents

Supplemental Materials

Write a Review

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