Pharmaceutical dissolution testing, bioavailability, and bioequivalence : Science, applications, and beyond

Delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing. Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence. Practical discussions about solubility, dissolution, permeability, and classification systems in drug development. In-depth examinations of the mechanics of dissolution, including mathematical models and simulations. An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications. A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products