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Applied Biopharmaceutics & Pharmacokinetics, Seventh Edition

Applied Biopharmaceutics & Pharmacokinetics, Seventh Edition

9780071830935
377,94 zł
359,04 zł Zniżka 18,90 zł Brutto
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Opis

The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics—now fully updated.

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  • Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them
  • Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency
  • Chapters have been revised to reflect the latest clinical perspectives on drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy

 

The fields leading text for more than three decades, Applied Biopharmaceutics & Pharmacokinetics gets you up to speed on the basics of the discipline like no other resource. Practical problems and clinical examples with discussions are integrated within each chapter to help you apply principles to patient care and drug consultation situations. In addition, outstanding pedagogy, including chapter objectives, chapter summaries, and FAQs, plus additional application questions, identify and focus on key concepts. 

 

Written by authors who have both academic and clinical experience, Applied

Biopharmaceutics & Pharmacokinetics shows you how to use raw data and formulate

the pharmacokinetic models and parameters that best describe the process of drug

absorption, distribution, and elimination. The book also helps you work with pharmacokinetic

and biopharmaceutic parameters to design and evaluate dosage 

regimens of drugs. In the seventh edition of this must-have interactive learning tool, most

of the chapters are updated to reflect our current understanding of complex issues

associated with safe and efficacious drug therapy. 

 

 

Szczegóły produktu
56869
9780071830935
9780071830935

Opis

Rok wydania
2015
Numer wydania
7
Oprawa
twarda
Liczba stron
928
Wymiary (mm)
196 x 239
Waga (g)
1794
  • 1. Introduction to Biopharmaceutics and Pharmacokinetics
    Drug Product Performance
    Biopharmaceutics
    Pharmacokinetics
    Pharmacodynamics
    Clinical Pharmacokinetics
    Practical Focus
    Pharmacodynamics
    Drug Exposure and Drug Response
    Toxicokinetics and Clinical Toxicology
    Measurement of Drug Concentrations
    Basic Pharmacokinetics and Pharmacokinetic Models
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    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
    3. Biostatistics
    Variables
    Types of Data (Nonparametric Versus Parametric)
    Distributions
    Measures of Central Tendency
    Measures of Variability
    Hypothesis Testing
    Statistically Versus Clinically Significant Differences
    Statistical Inference Techniques in Hypothesis Testing for Parametric Data
    Goodness of Fit
    Statistical Inference Techniques for Hypothesis Testing With Nonparametric Data
    Controlled Versus Noncontrolled Studies
    Blinding
    Confounding
    Validity
    Bioequivalence Studies
    Evaluation of Risk for Clinical Studies
    Chapter Summary
    Learning Questions
    Answers
    References
    4. One-Compartment Open Model:: Intravenous Bolus Administration
    Elimination Rate Constant
    Apparent Volume of Distribution
    Clearance
    Clinical Application
    Calculation of k From Urinary Excretion Data
    Practice Problem
    Practice Problem
    Clinical Application
    Chapter Summary
    Learning Questions
    Answers
    Reference
    Bibliography
    5. 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
    Practical Problem
    Clinical Application
    Practical Application
    Clinical Application
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    6. Intravenous Infusion
    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
    Reference
    Bibliography
    7. Drug Elimination, Clearance, and Renal Clearance
    Drug Elimination
    Drug Clearance
    Clearance Models
    The Kidney
    Clinical Application
    Practice Problems
    Renal Clearance
    Determination of Renal Clearance
    Practice Problem
    Practice Problem
    Relationship of Clearance to Elimination Half-Life and Volume of Distribution
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    8. Pharmacokinetics of Oral Absorption
    Introduction
    Basic Principles of Physiologically Based Absorption Kinetics (Bottom-Up Approach)
    Absoroption Kinetics (The Top-Down Approach)
    Pharmacokinetics of Drug Absorption
    Significance of Absorption Rate Constants
    Zero-Order Absorption Model
    Clinical Application—Transdermal Drug Delivery
    First-Order Absorption Model
    Practice Problem
    Chapter Summary
    Answers
    Application Questions
    References
    Bibliography
    9. 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
    10. Nonlinear Pharmacokinetics
    Saturable Enzymatic Elimination Processes
    Practice Problem
    Practice Problem
    Drug Elimination by Capacity-Limited Pharmacokinetics:: One-Compartment Model, IV Bolus Injection
    Practice Problems
    Clinical Focus
    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
    Potential Reasons for Unsuspected Nonlinearity
    Dose-Dependent Pharmacokinetics
    Clinical Example
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    11. Physiologic Drug Distribution and Protein Binding
    Physiologic Factors of Distribution
    Clinical Focus
    Apparent Volume Distribution
    Practice Problem
    Protein Binding of Drugs
    Clinical Examples
    Effect of Protein Binding on the Apparent Volume of Distribution
    Practice Problem
    Clinical Example
    Relationship of Plasma Drug–Protein Binding to Distribution and Elimination
    Clinical Examples
    Clinical Example
    Determinants of Protein Binding
    Clinical Example
    Kinetics of Protein Binding
    Practical Focus
    Determination of Binding Constants and Binding Sites by Graphic Methods
    Clinical Significance of Drug–Protein Binding
    Clinical Example
    Clinical Example
    Modeling Drug Distribution
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    12. Drug Elimination and Hepatic Clearance
    Route of Drug Administration and Extrahepatic Drug Metabolism
    Practical Focus
    Hepatic Clearance
    Extrahepatic Metabolism
    Enzyme Kinetics—Michaelis–Menten Equation
    Clinical Example
    Practice Problem
    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
    Hepatic Clearance of a Protein-Bound Drug:: Restrictive and Nonrestrictive Clearance From Binding
    Biliary Excretion of Drugs
    Clinical Example
    Role of Transporters on Hepatic Clearance and Bioavailability
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    13. Pharmacogenetics and Drug Metabolism
    Genetic Polymorphisms
    Cytochrome P-450 Isozymes
    Phase II Enzymes
    Transporters
    Chapter Summary
    Glossary
    Abbreviations
    References
    14. 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 to Questions
    References
    Bibliography
    15. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance
    Biopharmaceutic Factors and Rationale for Drug Product Design
    Rate-Limiting Steps in Drug Absorption
    Physicochemical Properties of the Drug
    Formulation Factors Affecting Drug Product Performance
    Drug Product Performance, In Vitro:: Dissolution and Drug Release Testing
    Compendial Methods of Dissolution
    Alternative Methods of Dissolution Testing
    Dissolution Profile Comparisons
    Meeting Dissolution Requirements
    Problems of Variable Control in Dissolution Testing
    Performance of Drug Products:: In Vitro–In Vivo Correlation
    Approaches to Establish Clinically Relevant Drug Product Specifications
    Drug Product Stability
    Considerations in the Design of a Drug Product
    Drug Product Considerations
    Clinical Example
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    16. 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 (PD) 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
    Pharmacokinetic Evaluation of the Data
    The Partial AUC in Bioequivalence Analysis
    Examples of Partial AUC Analyses
    Bioequivalence Examples
    Study Submission and Drug Review Process
    Waivers of In Vivo Bioequivalence Studies (Biowaivers)
    The Biopharmaceutics Classification System (BCS)
    Generic Biologics (Biosimilar Drug Products)
    Clinical Significance of Bioequivalence Studies
    Special Concerns in Bioavailability and Bioequivalence Studies
    Generic Substitution
    Glossary
    Chapter Summary
    Learning Questions
    Answers
    References
    17. Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence
    Introduction
    Pharmaceutical Alternatives
    Practice Problem
    Bioequivalence of Drugs With Multiple Indications
    Formulation and Manufacturing Process Changes
    Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
    Changes to an Approved NDA or ANDA
    The Future of Pharmaceutical Equivalence and Therapeutic Equivalence
    Biosimilar Drug Products
    Historical Perspective
    Chapter Summary
    Learning Questions
    Answers
    References
    18. Impact of Biopharmaceutics on Drug Product Quality and Clinical Efficacy
    Risks From Medicines
    Risk Assessment
    Drug Product Quality and Drug Product Performance
    Pharmaceutical Development
    Example of Quality Risk
    Excipient Effect on Drug Product Performance
    Practical Focus
    Quality Control and Quality Assurance
    Practical Focus
    Risk Management
    Scale-Up and Postapproval Changes (SUPAC)
    Practical Focus
    Product Quality Problems
    Postmarketing Surveillance
    Glossary
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    19. Modified-Release Drug Products and Drug Devices
    Modified-Release (MR) Drug Products and Conventional (Immediate-Release, IR) 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
    References
    Bibliography
    20. Targeted Drug Delivery Systems and Biotechnological Products
    Biotechnology
    Drug Carriers and Targeting
    Targeted Drug Delivery
    Pharmacokinetics of Biopharmaceuticals
    Bioequivalence of Biotechnology-Derived Drug Products
    Learning Questions
    Answers
    References
    Bibliography
    21. Relationship Between Pharmacokinetics and Pharmacodynamics
    Pharmacokinetics and Pharmacodynamics
    Relationship of Dose to Pharmacologic Effect
    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
    Chapter Summary
    Learning Questions
    Answers
    References
    22. 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 ond Dosing Interval on ... and ...
    Determination of Frequency of Drug Administration
    Determination of Both Dose and Dosage Interval
    Practice Problem
    Determination of Route of Administration
    Dosing Infants and Children
    Practice Problem
    Dosing the Elderly
    Practice Problems
    Clinical Example
    Dosing the Obese Patients
    Pharmacokinetics of Drug Interactions
    Inhibition of Drug Metabolism
    Inhibition of Monoamine Oxidase (MAO)
    Induction of Drug Metabolism
    Inhibition of Drug Absorption
    Inhibition of 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
    Regional Pharmacokinetics
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    23. Application of Pharmacokinetics to Specific Populations:: Geriatric, Obese, and Pediatric Patients
    Specific and Special Populations
    Module I:: Application of Pharmacokinetics to the Geriatric Patients
    Summary
    Learning Questions
    Answers
    References
    Further Reading
    Module II:: Application of Pharmacokinetics to the Obese Patients
    Summary
    Learning Questions
    Answers
    References
    Module III:: Application of Pharmacokinetics to the Pediatric Patients
    Summary
    Learning Questions
    Answers
    References
    24. Dose Adjustment in Renal and Hepatic Disease
    Renal Impairment
    Pharmacokinetic Considerations
    General Approaches for Dose Adjustment in Renal Disease
    Measurement of Glomerular Filtration Rate
    Serum Creatinine Concentration and Creatinine Clearance
    Practice Problems
    Dose Adjustment for Uremic Patients
    Practice Problem
    Practice Problem
    Practice Problems
    Practice Problem
    Extracorporeal Removal of Drugs
    Practice Problem
    Clinical Examples
    Effect of Hepatic Disease on Pharmacokinetics
    Practice Problem
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    25. Empirical Models, Mechanistic Models, Statistical Moments, and Noncompartmental Analysis
    Empirical Models
    Mechanistic Models
    Noncompartmental Analysis
    Comparison of Different Approaches
    Selection of Pharmacokinetic Models
    Chapter Summary
    Learning Questions
    Answers
    References
    Bibliography
    Appendix A Applications of Software Packages in Pharmacokinetics
    Appendix B Glossary
    Index
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