OpportunityTitle: Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)
AdditionalInformationOnEligibility: FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
Description: The purpose of this project is to conduct a prospective PK/PD study in attention deficit hyperactivity disorder (ADHD) patients to link the PK profiles to the time-course of PD activity of methylphenidate extended release products in order to identify additional PK metrics (if any) that may impact the therapeutic equivalence of methylphenidate extended release products. The findings from the PK/PD study will help establish scientific and regulatory standards for assuring therapeutic equivalence of generic methylphenidate extended release products.
GrantorContactEmailDescription: FDA OFFICE
GrantorContactText: Martin Bernard &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 240-402-7564