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• Title:Applied biopharmaceutics & pharmacokinetics / editors, Leon Shargel, Andrew B.C. Yu.
  
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• Variant Title:Applied biopharmaceutics and pharmacokinetics
  Shargel & Yu's Applied biopharmaceutics and pharmacokinetics
  
• Other Contributors/Collections:Shargel, Leon, 1941- editor, author.
  Yu, Andrew B. C., 1945- editor, author.
  
• Published/Created:New York : McGraw-Hill Education, [2016]
  

• Holdings

  Holdings Record Display

  • Location:BMB LIBRARY (VGH) stacksWhere is this?
    
  • Call Number: QV38 .A652 2016
    
  • Number of Items:1
    
  • Status:Available
    

  • Location:WOODWARD LIBRARY stacksWhere is this?
    
  • Call Number: QV38 .A652 2016
    
  • Number of Items:1
    
  • Status:Available
    

   
• Library of Congress Subjects:Biopharmaceutics.
  Pharmacokinetics.
  
• Medical Subjects: Biopharmaceutics.
  Pharmacokinetics.
  Drug Administration Routes.
  Models, Chemical.
  
• Edition:Seventh edition.
  
• Description:xvii, 910 pages : illustrations ; 24 cm
  
• Summary:The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics-now fully updated.
  
• Notes:Includes bibliographical references and index.
  
• ISBN:9780071830935 hardcover alkaline paper
  0071830936 hardcover alkaline paper
  
• Contents:Machine generated contents note: 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
  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
  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
  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
  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
  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 V, From Infusion Data
  Intravenous Infusion of Two-Compartment Model Drugs
  Practical Focus
  Chapter Summary
  Learning Questions
  Answers
  Reference
  Bibliography
  Drug Elimination
  Drug Clearance
  Clearance Models
  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
  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
  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
  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
  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
  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
  Genetic Polymorphisms
  Cytochrome P-450 Isozymes
  Phase II Enzymes
  Transporters
  Chapter Summary
  Glossary
  Abbreviations
  References
  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
  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
  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
  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)
  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
  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
  Future of Pharmaceutical Equivalence and Therapeutic Equivalence
  Biosimilar Drug Products
  Historical Perspective
  Chapter Summary
  Learning Questions
  Answers
  References
  Risks From Medicines
  Risk Assessment
  Contents note continued: 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
  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
  Biotechnology
  Drug Carriers and Targeting
  Targeted Drug Delivery
  Pharmacokinetics of Biopharmaceuticals
  Bioequivalence of Biotechnology-Derived , Drug Products
  Learning Questions
  Answers
  References
  Bibliography
  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
  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 Cinfinitymax, Cinfinitymin, and Cinfinityav
  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
  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
  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
  Empirical Models
  Mechanistic Models
  Noncompartmental Analysis
  Comparison of Different Approaches
  Selection of Pharmacokinetic Models
  Chapter Summary
  Learning Questions
  Answers
  References
  Bibliography.