Applied biopharmaceutics & pharmacokinetics

著者

• Shargel, Leon
• Yu, Andrew B. C.

書誌事項

Applied biopharmaceutics & pharmacokinetics

editors, Leon Shargel, Andrew B.C. Yu

McGraw-Hill Education, c2016

7th ed

タイトル別名

Applied biopharmaceutics and pharmacokinetics

注記

Includes bibliographical references and index

内容説明・目次

内容説明

The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics-now fully updated. 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 field's 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.

目次

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 Pharmaceuti cal 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

「Nielsen BookData」 より

詳細情報

• NII書誌ID(NCID): BB2220308X
• ISBN:
  • 9780071830935
• LCCN: 2015014810
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: New York
• ページ数/冊数: xvii, 910 p.
• 大きさ: 24 cm
• 分類:
  • LCC : RM301.4
  • NLM : QV 38
  • DC23 : 615.7
• 件名:
  • MESH : Biopharmaceutics
  • MESH : Pharmacokinetics
  • MESH : Drug Administration Routes
  • MESH : Models, Chemical