Int J Clin Pharm Th
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Int J Clin Pharm Th · Sep 2012
Meta AnalysisPopulation pharmacokinetic meta-analysis of intranasal fentanyl spray as a means to enrich pharmacokinetic information for patients with cancer breakthrough pain.
The development of intranasal fentanyl (INFS) aimed for a rapid treatment of breakthrough pain (BTP) in cancer patients. The pharmacokinetics (PK) of INFS was well characterized in healthy subjects, while PK investigations in cancer patients are limited. ⋯ A robust population PK model for INFS was developed. The model enhances the understanding of fentanyl PK after INFS dosing in cancer patients with BTP, a population for whom real-life data would be very hard to obtain.
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Int J Clin Pharm Th · Sep 2012
Editorial CommentModel-based drug approval - the rubber hits the road.