Oral Drug Absorption: Prediction and Assessment, Second Edition (Drugs and the Pharmaceutical Sciences)

The much anticipated Second Edition of Oral Drug Absorption thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. Case-based examples and a supplementary interactive CD-ROM are included to provide real-life approaches to testing. This practical, hands-on guide helps pharmaceutical industry personnel: model their own testing data using the Excel feature on the CD-ROM identify formulations that will produce the best clinical results clear products for release into the market verify batch-to-batch reproducibility identify whether changes in formulation or manufacturing procedure after marketing approval affect clinical performance determine if a generic version of the medicine can be approved The Second Edition’s new topics include: advances in pharmacokinetic modeling and profiling accurately establishing and validating in vitro and in vivo correlations for both MR and IR formulations methods used for synthetic drugs alternative approaches for MR and IR formulations bioequivalence studies and biowaiving dietary supplement considerations formulation screening and different approaches from the US industry and European industry perspectives