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The publication of this seventh edition of Applied Biopharmaceutics and Pharmacokinetics represents over three decades in print. Since the introduction of classic pharmacokinetics in the first edition, the discipline has expanded and evolved greatly. The basic pharmacokinetic principles and biopharmaceutics now include pharmacogenetics, drug receptor theories, advances in membrane transports, and functional physiology. These advances are applied to the design of new active drug moieties, manufacture of novel drug products, and drug delivery systems. Biopharmaceutics and pharmacokinetics play a key role in the development of safer drug therapy in patients, allowing individualizing dosage regimens and improving therapeutic outcomes.

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In planning for the seventh edition, we realized that we needed expertise for these areas. This seventh edition is our first edited textbook in which an expert with intimate knowledge and experience in the topic was selected as a contributor. We would like to acknowledge these experts for their precious time and effort. We are also grateful to our readers and colleagues for their helpful feedback and support throughout the years.

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As editors of this edition, we kept the original objectives, starting with fundamentals followed by a holistic integrated approach that can be applied to practice (see scope and objectives in Preface to the first edition). This textbook provides the reader with a basic and practical understanding of the principles of biopharmaceutics and pharmacokinetics that can be applied to drug product development and drug therapy. Practice problems, clinical examples, frequently asked questions and learning questions are included in each chapter to demonstrate how these concepts relate to practical situations. This textbook 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.

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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.

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This edition represents many significant changes from previous editions.

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  • The book is an edited textbook with the collaboration of many experts well known in biopharmaceutics, drug disposition, drug delivery systems, manufacturing, clinical pharmacology, clinical trials, and regulatory science.

  • Many chapters have been expanded and updated to reflect current knowledge and application of biopharmaceutics and pharmacokinetics. Many new topics and updates are listed in Chapter 1.

  • Practical examples and questions are included to encourage students to apply the principles in patient care and drug consultation situations.

  • Learning questions and answers appear at the end of each chapter.

  • Three new chapters have been added to this edition including, Biostatistics which provides introduction for popular topics such as risk concept, non-inferiority, and superiority concept in new drug evaluation, and Application of Pharmacokinetics in Specific Populations which discusses issues such as drug and patient related pharmacy topics in during therapy in various patient populations, and Biopharmaceutic Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence which explains the synthesis, quality and physical/chemical properties of the active pharmaceutical ingredients affect the bioavailability of the drug from the drug product and clinical efficacy.

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Leon Shargel
Andrew B.C. Yu

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