Biopharmaceutics modeling and simulations : theory, practice, methods, and applications / Kiyohiko Sugano

Includes bibliographical references and index.

Introduction -- Theoretical framework I : solubility -- Theoretical framework II : dissolution -- Theoretical framework III : biological membrane permeation -- Theoretical framework IV : gastrointestinal transit models and integration -- Physiology of gastrointestinal tract and other administration sites in humans and animals -- Drug parameters -- Validation of mechanistic models -- Bioequivalence and biopharmaceutical classification system -- Dose and particle size dependency -- Enabling formulations -- Food effect -- Biopharmaceutical modeling for miscellaneous cases -- Intestinal transporters -- Strategy in drug discovery and development -- Epistemology of biopharmaceutical modeling and good simulation practice

A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success.