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

[March 14, 2007]

By Turna Ray

FDA’s microdose exploratory studies, dubbed “Phase 0” at the FDA, “don’t give you the data that you want to have” before going into clinical development. However, a different type of service, called Phase Zero and provided by Asterand, relies on human tissues and may be right up pharma’s alley.

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