Drug product performance is a vital aspect of drug development as it draws on interdisciplinary expertise from both pharmaceutics and pharmacokinetics disciplines. It is at the key interface that the discipline of biopharmaceutics has emerged. The past two decades have witnessed considerable advances in biophar-maceutics particularly with regard to bioavailability and bioequivalence, as they relate to product quality and regulatory standards of approval.
While the foundation for biopharmaceutics has been laid by pioneers in the field and has been captured in early textbooks devoted to this area, a technical gap does exist on the current and emerging applications of regulatory aspects of biopharmaceutics. The current volume presents an integrated view linking pharmaceutics and the biological consequences to drug development decision making. The book is composed of carefully crafted chapters introducing fundamental concepts, methods, and advances in the area of dissolution, absorption, and permeability and their key applications in dosage form performance, with a specific focus on the applications of biopharmaceutical strategies in the development of successful drugs using case studies.
Chapter 1 introduces the basic concepts of biopharmaceutics and discusses the role of biopharmaceutics in various stages of drug development. Chapter 2 describes the molecular and physicochemical properties influencing drug absorption. Chapter 3 examines the utilities and limitations of dissolution testing and discusses biorelevant dissolution methods. Chapter 4 introduces the principles governing drug absorption. It includes all aspects of drug absorption including transport phenomena, factors influencing drug absorption, and methods to evaluate drug absorption. The current industrial practices of evaluating permeability, absorption, and p-glycoprotein interaction are presented in Chap. 5. Chapter 6 investigates the uses of pharmaceutical excipients in drug absorption as enhancers and proposes applications in dosage form design of mucoadhesive materials. Chapter 7 comprehensively describes various transporter families and outlines the role of intestinal transporters in drug absorption. Chapter 8 critically examines bioavailability and bioequivalence from a regulatory perspective, addresses issues inherent in the assessment and demonstration of bioequivalence. The mechanisms and strategies toward BCS are further outlined in Chap. 9. Further, the chapter introduces several case studies encompassing drugs from all BCS classes and multiple formulation types as examples of where a science-based approach to dissolution method characterization has been employed to determine rational product quality testing strategies. Chapter 10 discusses the impact of food in regulatory assessment of bioequivalence and proposes recommendations on the design of appropriate biopharmaceutics studies. Chapters 11 and 12 explore the applications of in vitro and in vivo correlation (IVIVC) for parenteral (Chap. 11) and orally administered drug products (Chap. 12).
We anticipate that the book will be helpful to individuals who work in the pharmaceutical industry in areas that apply pharmaceutics, biopharmaceutics, and pharmacokinetics, individuals who interact with formulation scientists and phar-macokineticists, as well as those who are in academic and research institutions. Since the fundamentals are also reviewed, we believe that the book will appeal to advanced undergraduate students and graduate students in pharmacy, pharmacology, and allied health professions.
We welcome comments and suggestions for improvement from our readers.
Rahway, NJ Rockville, MD
Rajesh Krishna Lawrence Yu
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