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This represents a boundary case where regulatory flexibility, combined with restricted labeling, enabled approval despite pharmacokinetic constraints that would preclude approval for most indications ( FIGURE 1 3.4 Sensitivity analysis: effects of bioavailability improvements and dosing frequency A legitimate question arises: could modest improvements in bioavailability or modified dosing strategies overcome the half-life constraint

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How quickly it degrades depends almost entirely on three factors: temperature, light exposure, and bacterial contamination

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