Leon Shargel Knihy

This comprehensive textbook on biopharmaceutics and pharmacokinetics has been a leading resource for over three decades. The sixth edition offers a foundational understanding of these principles and their application to drug product development, performance, and therapy. It uniquely addresses the complexities of ensuring safe and effective drug therapy. Authored by experts with both academic and clinical backgrounds, the text enables readers to grasp essential concepts in the field. Key learning outcomes include the ability to analyze raw data to derive pharmacokinetic models and parameters that accurately describe drug absorption, distribution, and elimination. Readers will also learn to critically evaluate biopharmaceutic studies related to drug product equivalency and design effective dosage regimens using pharmacokinetic and biopharmaceutic parameters. The book emphasizes detecting clinical pharmacokinetic issues and applying basic principles to resolve them. Each chapter features practical problems and clinical examples to facilitate the application of concepts to patient care and drug consultation. Additionally, Chapter Objectives, Summaries, and Frequently Asked Questions guide readers in focusing on key ideas. Most chapters have been updated to reflect the latest insights into drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy.

Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.