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Advanced Drug Delivery Reviews

ISSN 0169-409X

1 paper in the library · 60 citations · publishing 2010

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Impact of microdosing clinical study — Why necessary and how useful?

Advanced Drug Delivery Reviews October 14, 2010 Yuichi Sugiyama, Shinji Yamashita 60 citations

The microdose (MD) clinical study enables to select a "better" compound for new drug candidate that shows desirable PK profiles in human. This new methodology is highly expected to streamline the drug development and to increase the success probability in the clinical trial. Since only a small amount of the test compound (less than 100 μg) is administered, the risk of harmful events to a human...