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.
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
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.
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
• 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
• 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.
learning and outcome-based objectives are highlighted.
Andrew B.C. Yu