Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.
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DOI: 10.1021/acs.molpharmaceut.4c00479
Abstract: Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products… read more here.
Keywords: bioequivalence; inhaled drug; single maximum; drug products ... See more keywords