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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

This highly sensitive method even works to detect package defects clogged by product formulation proteins or salts, explains Liss. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. Tox Tree and grouping by Cramer rules are starting to lose favor with the FDA.