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This work emphasizes the application and understanding of core areas involving bioavailability, population pharmacokinetics, pharmacodynamics, metabolism and drug delivery.

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• Preface(p. XIII)
• 1. Review of Mathematical Fundamentals(p. 1)
• Estimation and the Use of Calculators and Computers(p. 1)
• Calculus(p. 6)
• Graphs(p. 9)
• Units in Pharmacokinetics(p. 16)
• Measurement and the Use of Significant Figures(p. 17)
• Units for Expressing Blood Concentrations(p. 18)
• Statistics(p. 18)
• Rates and Orders of Reactions(p. 21)
• Frequently Asked Questions(p. 26)
• Learning Questions(p. 26)
• References(p. 28)
• Bibliography(p. 28)
• 2. Introduction to Biopharmaceutics and Pharmacokinetics(p. 29)
• Biopharmaceutics(p. 29)
• Pharmacokinetics(p. 30)
• Clinical Pharmacokinetics(p. 30)
• Pharmacodynamics(p. 31)
• Toxicokinetics and Clinical Toxicology(p. 31)
• Measurement of Drug Concentrations(p. 32)
• Basic Pharmacokinetics and Pharmacokinetic Models(p. 36)
• Frequently Asked Questions(p. 43)
• Learning Questions(p. 43)
• References(p. 44)
• Bibliography(p. 45)
• 3. One-Compartment Open Model(p. 47)
• Intravenous Route of Administration of Drug(p. 47)
• Elimination Rate Constant(p. 48)
• Apparent Volume of Distribution(p. 49)
• Clearance(p. 52)
• Calculation of k from Urinary Excretion Data(p. 58)
• Clinical Application(p. 62)
• Frequently Asked Questions(p. 63)
• Learning Questions(p. 64)
• Bibliography(p. 66)
• 4. Multicompartmental Models(p. 67)
• Two-Compartment Open Model(p. 69)
• Three-Compartment Open Model(p. 85)
• Determination of Compartment Models(p. 88)
• Frequently Asked Questions(p. 95)
• Learning Questions(p. 95)
• References(p. 98)
• Bibliography(p. 98)
• 5. Physiologic Factors Related to Drug Absorption(p. 99)
• Nature of the Cell Membrane(p. 99)
• Passage of Drugs Across Cell Membranes(p. 101)
• Route of Drug Administration(p. 108)
• Frequently Asked Questions(p. 125)
• Learning Questions(p. 126)
• References(p. 127)
• Bibliography(p. 128)
• 6. Biopharmaceutic Considerations in Drug Product Design(p. 129)
• Rate-Limiting Steps in Drug Absorption(p. 130)
• Pharmaceutic Factors Affecting Drug Bioavailability(p. 131)
• Physicochemical Nature of the Drug(p. 133)
• Formulation Factors Affecting Drug Dissolution(p. 135)
• In Vitro Dissolution Testing(p. 138)
• Compendial Methods of Dissolution(p. 140)
• Methods for Testing Enteric-Coated Products(p. 143)
• Meeting Dissolution Requirements(p. 143)
• Unofficial Methods of Dissolution Testing(p. 144)
• Problems of Variable Control in Dissolution Testing(p. 145)
• In Vitro-In Vivo Correlation of Dissolution(p. 146)
• Failure of Correlation of In Vitro Dissolution to In Vivo Absorption(p. 150)
• Biopharmaceutic Considerations(p. 151)
• Pharmacodynamic Considerations(p. 152)
• Drug Considerations(p. 152)
• Drug Product Considerations(p. 152)
• Patient Considerations(p. 154)
• Route of Drug Administration(p. 154)
• Clinical Example(p. 160)
• Frequently Asked Questions(p. 164)
• Learning Questions(p. 164)
• References(p. 165)
• Bibliography(p. 165)
• 7. Modified-Release Drug Products(p. 169)
• Modified-Release Drug Products(p. 169)
• Biopharmaceutic Factors(p. 172)
• Dosage Form Selection(p. 174)
• Drug Release from Matrix(p. 174)
• Advantages and Disadvantages of Extended-Release Products(p. 175)
• Kinetics of Controlled-Release Dosage Forms(p. 176)
• Pharmacokinetic Simulation of Extended-Release Products(p. 178)
• Types of Extended-Release Products(p. 180)
• Considerations in the Evaluation of Modified-Release Products(p. 193)
• Regulatory Studies for the Evaluation of Modified-Release Products(p. 195)
• Evaluation of In Vivo Bioavailability Data(p. 198)
• Frequently Asked Questions(p. 200)
• Learning Questions(p. 200)
• References(p. 201)
• Bibliography(p. 202)
• 8. Targeted Drug Delivery Systems and Biotechnological Products(p. 205)
• Targeted Drug Delivery(p. 205)
• Biotechnology(p. 207)
• Bioequivalence of Biotechnology Products(p. 219)
• Frequently Asked Questions(p. 220)
• Learning Questions(p. 220)
• References(p. 220)
• Bibliography(p. 221)
• 9. Pharmacokinetic Model of Oral Absorption(p. 223)
• Pharmacokinetics of Drug Absorption(p. 223)
• Zero-Order Absorption Model(p. 224)
• First-Order Absorption Model(p. 225)
• Significance of Absorption Rate Constants(p. 242)
• Frequently Asked Questions(p. 242)
• Learning Questions(p. 243)
• References(p. 244)
• Bibliography(p. 245)
• 10. Bioavailability and Bioequivalence(p. 247)
• Definitions(p. 247)
• Purpose of Bioavailability Studies(p. 249)
• Relative and Absolute Availability(p. 250)
• Methods for Assessing Bioavailability(p. 252)
• Bioequivalence Studies(p. 256)
• Design and Evaluation of Bioequivalence Studies(p. 259)
• Bioequivalence Example(p. 265)
• Generic Substitution(p. 271)
• Frequently Asked Questions(p. 272)
• Learning Questions(p. 273)
• References(p. 278)
• Bibliography(p. 279)
• 11. Physiologic Drug Distribution and Protein Binding(p. 281)
• Physiologic Factors(p. 281)
• Calculation of Apparent Volume of Distribution(p. 299)
• Protein Binding of Drugs(p. 303)
• Kinetics of Protein Binding(p. 306)
• Determination of Binding Constants and Binding Sites by Graphic Methods(p. 309)
• Clinical Significance of Drug-Protein Binding(p. 313)
• Frequently Asked Questions(p. 320)
• Learning Questions(p. 320)
• References(p. 322)
• Bibliography(p. 323)
• 12. Durg Elimination and Clearance Concepts(p. 325)
• Drug Elimination(p. 325)
• The Kidney(p. 326)
• Drug Clearance(p. 333)
• Physiologic Approach to Clearance(p. 335)
• Renal Clearance(p. 336)
• Renal Drug Excretion(p. 337)
• Drug Clearance(p. 340)
• Determination of Renal Clearance(p. 341)
• Relationship of Clearance Elimination Half-Life and Volume of Distribution(p. 347)
• Frequently Asked Questions(p. 349)
• Learning Questions(p. 350)
• References(p. 351)
• Bibliography(p. 351)
• 13. Hepatic Elimination of Drugs(p. 353)
• Fraction of Drug Excreted Unchanged (f[subscript e]) and Fraction of Drug Metabolized (1 - f[subscript e])(p. 354)
• Clinical Focus(p. 355)
• Pharmacokinetics of Drugs and Metabolites(p. 355)
• Anatomy and Physiology of the Liver(p. 362)
• Hepatic Enzymes Involved in the Biotransformation of Drugs(p. 365)
• Drug Biotransformation Reactions(p. 366)
• Route of Drug Administration and Extrahepatic Drug Metabolism(p. 376)
• First-Pass Effects(p. 377)
• Hepatic Clearance(p. 383)
• Significance of Drug Metabolism(p. 389)
• Biliary Excretion of Drugs(p. 390)
• Frequently Asked Questions(p. 393)
• Learning Questions(p. 393)
• References(p. 396)
• Bibliography(p. 397)
• 14. Intravenous Infusion(p. 399)
• One-Compartment Model Drugs(p. 399)
• Infusion Method for Calculating Patient Elimination Half-Life(p. 404)
• Loading Dose Plus IV Infusion(p. 406)
• Estimation of Drug Clearance and V[subscript D] from Infusion Data(p. 412)
• Estimation of k and V[subscript D] of Aminoglycosides in Clinical Situations(p. 412)
• Intravenous Infusion of Two-Compartment Model Drugs(p. 413)
• Frequently Asked Questions(p. 414)
• Learning Questions(p. 415)
• References(p. 417)
• Bibliography(p. 417)
• 15. Multiple-Dosage Regimens(p. 419)
• Drug Accumulation(p. 419)
• Repetitive Intravenous Injections(p. 424)
• Intermittent Intravenous Infusion(p. 430)
• Multiple Oral Dose Regimen(p. 433)
• Loading Dose(p. 436)
• Determination of Bioavailability and Bioequivalence in a Multiple-Dose Regimen(p. 437)
• Bioequivalence Studies(p. 438)
• Dosage Regimen Schedules(p. 441)
• Frequently Asked Questions(p. 445)
• Learning Questions(p. 445)
• References(p. 446)
• Bibliography(p. 447)
• 16. Nonlinear Pharmacokinetics(p. 449)
• Saturable Enzymatic Elimination Processes(p. 451)
• Drug Elimination by Capacity-Limited Pharmacokinetics: One-Compartment Mode, IV Bolus Injection(p. 454)
• Equations for Drugs Distributed as One-Compartment Model and Eliminated by Nonlinear Pharmacokinetics(p. 467)
• Time-Dependent Pharmacokinetics(p. 468)
• Bioavailability of Drugs That Follow Nonlinear Pharmacokinetics(p. 469)
• Nonlinear Pharmacokinetics Due to Drug-Protein Binding(p. 469)
• Frequently Asked Questions(p. 472)
• Learning Questions(p. 472)
• References(p. 473)
• Bibliography(p. 474)
• 17. Application of Pharmacokinetics in Clinical Situations(p. 475)
• Individualization of Drug Dosage Regimen(p. 475)
• Therapeutic Drug Monitoring(p. 476)
• Design of Dosage Regimens(p. 484)
• Conversion From Intravenous Infusion to Oral Dosing(p. 485)
• Determination of Dose(p. 487)
• Effect of Changing Dose and Dosing Interval on C[subscript max][infinity], C[subscript min][infinity],and C[subscript av][infinity](p. 489)
• Determination of Frequency of Drug Administration(p. 490)
• Determination of Both Dose and Dosage Interval(p. 491)
• Nomograms and Tabulations in Designing Dosage Regimens(p. 492)
• Determination of Route of Administration(p. 493)
• Dosing of Drugs in Infants and Children(p. 494)
• Dosing of Drugs in the Elderly(p. 496)
• Dosing of Drugs in the Obese Patient(p. 500)
• Pharmacokinetics of Drug Interactions(p. 501)
• Inhibition of Drug Metabolism(p. 504)
• Inhibition of Biliary Excretion(p. 506)
• Induction of Drug Metabolism(p. 506)
• Altered Renal Reabsorption Due to Changing Urinary pH(p. 506)
• Inhibition of Drug Absorption(p. 507)
• Effect of Food on Drug Disposition(p. 507)
• Adverse Viral Drug Interactions(p. 508)
• Population Pharmacokinetics(p. 508)
• Frequently Asked Questions(p. 522)
• Learning Questions(p. 523)
• References(p. 526)
• Bibliography(p. 528)
• 18. Dosage Adjustment in Renal and Hepatic Disease(p. 531)
• Pharmacokinetic Considerations(p. 531)
• General Approaches for Dose Adjustment in Renal Disease(p. 532)
• Dose Adjustment Based on Drug Clearance(p. 533)
• Method Based on Changes in the Elimination Rate Constant(p. 534)
• Measurement of Glomerular Filtration Rate(p. 535)
• Serum Creatinine Concentration and Creatinine Clearance(p. 536)
• Dosage Adjustment for Uremic Patients(p. 541)
• Extracorporeal Removal of Drugs(p. 554)
• Dialysis(p. 555)
• Hemoperfusion(p. 561)
• Hemofiltration(p. 561)
• Effect of Hepatic Disease on Pharmacokinetics(p. 562)
• Frequently Asked Questions(p. 567)
• Learning Questions(p. 568)
• References(p. 569)
• Bibliography(p. 570)
• 19. Relationship Between Pharmacokinetic and Pharmacodynamics(p. 573)
• Pharmacodynamics and Pharmacokinetics(p. 573)
• Relation of Dose to Pharmacologic Effect(p. 575)
• Relationship Between Dose and Duration of Activity (t[subscript eff]), Single IV Bolus Injection(p. 577)
• Effect of Both Dose and Elimination Half-Life on the Duration of Activity(p. 579)
• Effect of Elimination Half-Life on Duration of Activity(p. 580)
• Rate of Drug Absorption and Pharmacodynamic Response(p. 584)
• Drug Tolerance and Physical Dependency(p. 585)
• Hypersensitivity and Adverse Response(p. 586)
• Drug Distribution and Pharmacologic Response(p. 587)
• Pharmacodynamic Models(p. 590)
• Frequently Asked Questions(p. 603)
• Learning Questions(p. 603)
• References(p. 604)
• Bibliography(p. 605)
• 20. Physiologic Pharmacokinetic Models, Mean Residence Time, and Statistical Moment Theory(p. 607)
• Physiologic Pharmacokinetic Models(p. 608)
• Mean Residence Time (MRT)(p. 619)
• Statistical Moment Theory(p. 624)
• Mean Absorption Time (MAT) and Mean Dissolution Time (MDT)(p. 635)
• Selection of Pharmacokinetic Models(p. 637)
• Frequently Asked Questions(p. 639)
• Learning Questions(p. 639)
• References(p. 640)
• Bibliography(p. 641)
• Appendix A Statistics(p. 643)
• Appendix B Application of Computers in Pharmacokinetics(p. 653)
• Appendix C Solutions to Frequently Asked Questions (FAQ) and Learning Questions(p. 667)
• Appendix D Guiding Principles for Human and Animal Research(p. 727)
• Appendix E Popular Drugs and Pharmacokinetic Parameters(p. 731)
• Appendix F Glossary(p. 737)
• Index(p. 739)