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BioPharmaceutical United States Advisory Committees

Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says

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Executive Summary

FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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