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If the predicted purge ratio is < 100, then ICH M7 Option 4 may not be an appropriate strategy unless it can be supported by further substantive experimental data. While it is possible that an Option 4 approach might still be valid in view of the inherent underestimation of the purge estimate approach, a predicted purge of <100 alone was viewed as insufficient to support an Option 4 approach. Therefore, measured purge factors, based on both batch data, and deliberate spiking and purge studies, would be required to support an Option 4 proposal.