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9780071375504

Applied Biopharmaceutics & Pharmacokinetics, Fifth Edition

by ; ;
  • ISBN13:

    9780071375504

  • ISBN10:

    0071375503

  • Edition: 5th
  • Format: Hardcover
  • Copyright: 2004-08-19
  • Publisher: McGraw-Hill Medical
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List Price: $82.26

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.

Author Biography

Leon Shargel, PhD is vice president of biopharmaceutics at Eon Labs, Inc. Wilson, NC., Susanna Wu-Pong, PhD, RPh is an associate professor in the department of pharmaceutics at Virginia Commonwealth University, Richmond, Virginia, Andrew B.C. Yu,PhD, RPh, formerly a professor at the Albany College of Pharmacy, is currently with the FDA in Rockville, MD.

Table of Contents

Preface xv
Glossary xvii
1. INTRODUCTION TO BIOPHARMACEUTICS AND PHARMACOKINETICS
1(20)
Biopharmaceutics
1(2)
Pharmacokinetics
3(1)
Clinical Pharmacokinetics
3(1)
Pharmcodynamics
4(1)
Toxicokinetics and Clinical Toxicology
4(1)
Measurement of Drug Concentrations
5(4)
Basic Pharmacokinetics and Pharmacokinetic Models
9(9)
References
18(1)
Bibliography
18(3)
2. MATHEMATIC FUNDAMENTALS IN PHARMACOKINETICS
21(30)
Math Self-Exam
21(1)
Estimation and the Use of Calculators and Computers
22(5)
Calculus
27(3)
Graphs
30(7)
Units in Pharmacokinetics
37(1)
Measurement and Use of Significant Figures
38(1)
Units for Expressing Blood Concentrations
39(1)
Statistics
39(3)
Rates and Orders of Reactions
42(5)
Frequently Asked Questions
47(1)
Learning Questions
48(2)
References
50(1)
Bibliography
50(1)
3. ONE-COMPARTMENT OPEN MODEL: INTRAVENOUS BOLUS ADMINISTRATION
51(22)
Elimination Rate Constant
52(1)
Apparent Volume of Distribution
53(4)
Clearance
57(6)
Calculation of K from Urinary Excretion Data
63(6)
Frequently Asked Questions
69(1)
Learning Questions
69(3)
Reference
72(1)
Bibliography
72(1)
4. MULTICOMPARTMENTAL MODELS: INTRAVENOUS BOLUS ADMINISTRATION
73(32)
Two-Compartment Open Model
75(18)
Three-Compartment Open Model
93(2)
Determination of Compartment Models
95(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

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