Shargel and Yu’s Applied Biopharmaceutics and Pharmacokinetics, 8E

This authoritative guide has been updated with important new findings about drug therapy, product performance, and other need-to-know topics!

Applied Biopharmaceutics & Pharmacokinetics, Eighth Edition delivers the knowledge and skills you need to succeed. The authors provide practical problems with specific examples of clinical solutions to help you apply principles to patient care and drug consultation situations. Each chapter includes objectives, summaries, and FAQs highlighting that help you understand and retain key concepts. You’ll learn how to derive models/parameters to describe drug absorption, distribution, and elimination processes, evaluate biopharmaceutic studies involving drug product equivalency and unequivalency, design and evaluate dosage regimens of drugs, detect and solve clinical pharmacokinetic problems, and much more.

Biopharmaceutics and pharmacokinetics play a key role in the development of safer and
more efficacious drug products. Application of these concepts makes possible better and
more successful drug therapy in patients, allowing individualizing dosage regimens and
improving therapeutic outcomes. Biopharmaceutic and pharmacokinetic principles are
essential in the development of new and novel dosage forms.
Scientific developments and innovations in biopharmaceutics and pharmacokinetics have
expanded exponentially since publication of the first edition in 1980. The first edition was
based on a collaboration of two colleagues who saw a need to provide students with
supplementary material to a pharmacy course. The objectives of the first edition were to:
1. Define the basic concepts in biopharmaceutics and pharmacokinetics.
2. Use raw data and derive the pharmacokinetic models and parameters that best
describe the process of drug absorption, distribution, and elimination.
3. Critically evaluate biopharmaceutic studies involving drug product equivalency and
unequivalency.
4. Design and evaluate dosage regimens of drugs using pharmacokinetic and
biopharmaceutic parameters.
5. Detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic
principles to solve them.
These basic objectives have been incorporated into each subsequent edition of this
textbook. Due to the expansion of knowledge in this discipline, the authors saw a need for
an edited edition that would include experts from academia, pharmaceutical research, and
regulatory affairs. As editors of this edition, we kept the original objectives, starting with
fundamental concepts followed by a holistic integrated approach that can be applied to
practice. The contributors were tasked to provide objectives for each chapter that were
commensurate with the overall objectives.
The publication of the eighth edition of Shargel and Yu’s Applied Biopharmaceutics and
Pharmacokinetics embodies more than four decades of scientific developments in the field.
In planning for the eighth edition, we realized the need to organize the chapters in a more
logical sequence starting with introductory and fundamental principles, developing these
basic concepts and then applying these concepts to clinical situations. The new edition ends
with a discussion of biopharmaceutics and pharmacokinetics in drug product development.
The eighth edition represents the collective contribution of experts with intimate knowledge
and experience in the selected subject areas. Each chapter was written to include practical
applications of the theoretical material. Frequently asked questions are included to provide
a discussion of overall concepts. Practice problems, clinical examples and learning questions
are included in each chapter to show how these concepts relate to practical situations.
This textbook remains unique in teaching basic concepts that may be applied to
understanding complex issues that are essential for understanding drug development and
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, technological and development scientists in pharmaceutics,
biopharmaceutics, and pharmacokinetics.
We would like to acknowledge the contributions of Andrew B.C. Yu, PhD. Dr. Yu provided
valuable expertise in the writing of the first six editions and in editing the seventh edition of
this textbook. Dr. Yu’s input helped with the success of this textbook. As the first author, I
would also like to acknowledge the input of our new editor, Murray Ducharme, PharmD. Dr.
Ducharme has provided substantial guidance and expertise in organizing and editing this
new eighth edition of Shargel and Yu’s Applied Biopharmaceutics and Pharmacokinetics.
We are grateful to our contributors, readers, colleagues and students for their helpful
feedback and support throughout the years.
Leon Shargel, PhD
Murray P. Ducharme, PharmD