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The publication of this sixth edition of Applied Biopharmaceutics and Pharmacokinetics represents over 30 years in print. We are grateful to our readers for their loyalty and helpful suggestions throughout the years. As with the previous editions, we want to continue to maintain our original scope and objectives.

This text integrates basic scientific principles with drug product development and clinical pharmacy practice.

The major objective is to provide the reader with a basic and practical understanding of the principles of biopharmaceutics and pharmacokinetics that can be applied to drug product development and to drug therapy. This revised and updated edition of the text remains unique in teaching basic concepts that may be applied to understanding complex issues associated with in vivo drug delivery that are essential for safe and efficacious drug therapy.

The primary audience is pharmacy students enrolled in pharmaceutical science courses in pharmacokinetics and biopharmaceutics. This text fulfills course work offered in separate or combined courses in these subjects. Secondary audiences for this textbook are research and development scientists in pharmaceutics, biopharmaceutics, and pharmacokinetics.

There are many improvements in this edition.

Chapter Summary at the end of each chapter.
Frequently Asked Questions are seeded within each chapter to help the student focus on key concepts.
• Most chapters are revised to reflect our current understanding of drug disposition, pharmacodynamics, and drug therapy.
• The growing importance of drug transporters, CYP enzymes, and influence of pharmacogenetics on long-term drug response and other relevant topics have been updated to reflect current knowledge and application of pharmacokinetic/pharmacodynamics to drug therapy.
Chapter 15 is expanded and re-titled, Drug Product Performance, In Vivo: Bioavailability and Bioequivalence, to reflect the consideration of bioequivalence as an in vivo measure of drug product performance and that bioequivalence is important in both brand and generic drug product development.
Chapter 16 is now titled, Impact of Drug Product Quality and Biopharmaceutics on Clinical Efficacy. This chapter describes the types of safety and efficacy risks and various means for preventing them including the roles of drug product quality and drug product performance.
• In addition, the concept of quality-bydesign (QbD) may be applied to improve critical quality attributes essential for drug product safety and efficacy
Practical examples and questions are included to encourage students to apply the principles in patient care and drug consultation situations.
Active learning and outcome-based objectives are highlighted.

Leon Shargel
Susanna Wu-Pong
Andrew B.C. Yu

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