FDA's 'Phase 0' Microdosing Studies Not Useful Preclinical Tool, Pharma Exec Says

Mar 14, 2007

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PHILADELPHIA — Pre-clinical microdosing studies aimed at gauging the activity of investigational drugs in humans on a metabolic and pharmacokinetic level, commonly referred to as “Phase 0” studies, won’t predict whether a drug candidate will succeed or fail at higher doses and in broader populations, a Novartis exec said last week.

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