Description:
The authoritative textbook on the principles and practical applications of biopharmaceutics and pharmacokinetics
Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics has been the standard textbook in its field for over 40 years. This eighth edition includes recent scientific developments in the field and embodies the collective contribution of experts with deep knowledge and experience in the selected subject areas. Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition provides the reader with a fundamental understanding of biopharmaceutics and pharmacokinetics principles that can be applied to patient drug therapy and rational drug product development.
Shargel & Yu's Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition has been expanded and revised to include advancements in biopharmaceutics and pharmacokinetics. The chapter sequence has been reorganized into four main sections, providing a more logical sequence for students. The textbook starts with fundamental concepts, followed by application of these principles to optimize drug therapy and to the rational development of drug products. Each chapter includes theoretical concepts with practical examples and clinical applications. Frequently asked questions provide a discussion of overall concepts.
Features:
⚫ Expanded and revised chapters to include scientific advances in biopharmaceutics and pharmacokinetics
⚫ Four main sections providing a natural buildup of knowledge: introduction to biopharmaceutics and
pharmacokinetics, fundamentals of biopharmaceutics, pharmacokinetic calculations, clinical pharmacokinetics
and pharmacodynamics, and biopharmaceutics and pharmacokinetics in drug product development
⚫ Additional chapters for this edition include:
o Physiological factors related to drug absorption
o Approaches to pharmacokinetics and pharmacodynamics calculations
o Novel and complex dosage Forms
o Clinical Development and Therapeutic Equivalence of Generic Drug and Biosimilar Products
o Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development
⚫ Additional information on drug therapy, drug product performance, and other related topics⚫ Frequently asked questions, practice problems, clinical examples and learning questions
- Table of Contents -
PART I
Introduction to Biopharmaceutics and Pharmacokinetics
Chapter 1. Introduction to Biopharmaceutics and Pharmacokinetics
Chapter 2. Mathematical Fundamentals in Pharmacokinetics
Chapter 3. Biostatistics
PART II
Fundamentals of Biopharmaceutics
Chapter 4. Physiologic Factors Related to Drug Absorption
Chapter 5. Drug Distribution and Protein Binding
Chapter 6. Physiology of Drug Elimination
Chapter 7. Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance
Chapter 8. Drug Product Performance, In Vivo : Bioavailability and Bioequivalence
Chapter 9. Modified-Release Drug Products and Drug Devices
Chapter 10. Targeted Drug Delivery Systems and Biotechnoloy Products
PART III
Pharmacokinetic Principles
Chapter 11. Introduction to Pharmacokinetic and Pharmacodynamic Models and Analyses
Chapter 12. One-Compartment Open Model: Intravenous Bolus Administration
Chapter 13. Multicompartment Models: Intravenous Bolus Administraion
Chapter 14. Intravenous Infusion
Chapter 15. Pharmacokinetic Calculations for Drug Elimination and Clearance
Chapter 16. Pharmacokinetics of Drug Absorption
Chapter 17. Multiple-Dosage Regimens
Chapter 18. Nonlinear Pharmacokinetics
Chapter 19. Empirical Models, Mechanistic Models, Statistical Moments, and Noncompartmental PK/PD Analyses
Chapter 20. Applications of Software Packages in Pharmacokinetics
PART IV
Pharmacodynamics and Clinical Pharmacokinetics
Chapter 21. Pharmacogenetics, Drug Metabolism, Transporters, and Individualization
Chapter 22. Relationship between Pharmacokinetics and Pharmacodynamics
Chapter 23. Application of Pharmacokinetics to Clinical Situations
Chapter 24. Applicarion of Pharmacokinetics and Pharmacodynamics to Aging, Obese, and Pediatric Patients
Chapter 25. Dose Adjustment in Renal and Hepatic Diseases
PART V
Biopharmaceutics and Pharmacokinetics in Drug Product Development
Chapter 26. Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence
Chapter 27. Rational Drug Development, Quality, and Performance
Chapter 28. FDA-Approved Novel Dosage Forms
Chapter 29. Clinical Development and Therapeutic Equivalence of Generic Drugs and Biosimilar Products
Chapter 30. Pharmacokinetics and Pharmacodynamics in Clinical Drug Product Development