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Inder Chaudhary
Imbrium Therapeutics, 201 Tresse Blvd, Stanford, CT 06901, USA
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Research Article
Pharmacokinetic/Pharmacodynamic Model for Aptensio XR® (an Extended-Release Methylphenidate Formulation) in 6-12 year-old Children
Author(s): Andre J Jackson* and Inder Chaudhary
Aptensio XR® is an Extended-Release (ER) Methylphenidate (MPH) capsule drug product, approved for use in patients 6 years and older. Absorption of Aptensio XR® in children has been characterized by a fast first-order release and a delayed, slow first-order release. The current study investigated a Pharmacokinetic (PK) and Pharmacodynamic (PD) model for children 6-12 years-old (N=15). Determination of the PK parameters’ accuracy for pAUC (partial area under the curve) for times 0-3, 3-7, and 7-12 hours), Cmax (maximum concentration), and AUC0-T (area from time 0 to time T), for the 6-12 year-olds was calculated. All had bias less than 15% from the true observed values except for pAUC0-3 and Cmax. This study also compared the current PD parameters with those previously reported from a meta- analysi.. View more»