Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR and IR formulations.
This practical, hands-on guide includes an interactive CD-ROM that helps pharmaceutical industry personnel model their own testing data. They will learn how to identify formulations that will produce the best clinical results and verify batch-to-batch reproducibility. They will also understand how to identify whether changes in formulation or manufacturing procedure after marketing approval affect clinical performance, and how to determine if a generic version of the medicine can be approved
This edition includes information about bioequivalence studies, biowaiving, formulation screening, and different approaches from U.S. industry and European industry perspectives. It also reviews major advances in pharmacokinetic modeling and profiling. Case-based examples are included to clarify the material.
Table of Contents
Physiology of Oral Drug Absorption. The Biopharmaceutics Classification System. Nonclinical Methods to Evaluate Oral Formulations. Bioequivalence Studies.
Jennifer B. Dressman, Christos Reppas