12:00 AM
Mar 14, 2005
 |  BioCentury  |  Product Development

Proof of principle for Phase 0

About one in three compounds fail in Phase I trials because of pharmacokinetic, pharmacodynamic or toxicity issues that in vitro or animal models have not predicted. Human microdosing studies are one potential approach to reducing this attrition rate while saving money on several fronts, from toxicology to chemistry, manufacturing and controls (CMC). But there has been little hard proof that microdose data are predictive of the pharmacokinetics of compounds at full dosing.

Now, a consortium of pharma companies, CRO Pharma Bio-Research BV (Zuitlaren, the Netherlands), and bioanalytics play Xceleron Ltd. (York, U.K.) thinks it has gathered evidence to validate the microdosing concept. Among the pharma companies were Roche (SWX:ROCZ, Basel, Switzerland), Eli Lilly and...

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