Автор: Jennifer B. Dressman and Christos Reppas
Название: Oral Drug Absorption: Prediction and Assessment, 2nd Edition
Издательство: CRC Press
Год: 2009
ISBN: 9781420077339; 1420077333
Серия: Drugs and the Pharmaceutical Sciences (Book 193)
Язык: English
Формат: pdf
Размер: 13,2 mb
Страниц: 450

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 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.