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.
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Oral Drug Absorption: Prediction and Assessment, 2nd Edition 
