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The stability data that would ordinarily accompany a licensed product including International Council for Harmonisation (ICH) Q1A(R2)-compliant long-term and accelerated stability studies have not been published in a form accessible to prescribers or patients

[3] [253] Evidence from studies that measured the effect of serum DBH concentrations on 4-hydroxyamphetamine metabolism in humans suggests that a different enzyme may mediate the conversion of 4-hydroxyamphetamine to 4-hydroxynorephedrine

Taheur FB, et al

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