Accium BioSciences, Inc. Announces FDA Clears Path For Exploratory IND Studies
10/19/2005 5:12:42 PM
SEATTLE--(BUSINESS WIRE)--April 14, 2005--Accium BioSciences today announced that the FDA has issued draft guidance that clarifies preclinical and clinical considerations in preparation of "Microdosing" or "Phase 0" clinical studies in the US. The guidance clears the path for drug developers in the US to obtain important pharmacokinetic information at a much earlier stage of clinical development using Exploratory IND studies. The new FDA guidance contains details about a new investigational drug application process, the "Exploratory IND" that will enhance post-discovery drug development.
"Exploratory IND studies can help identify, early in the process, promising candidates for continued development, and eliminate those lacking promise. As a result, exploratory IND studies may help reduce the number of human subjects and resources, including the amount of candidate product, needed to select promising drugs," said the FDA.
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