Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)
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.
General information about this opportunity
Last Known Status
Deleted 07/11/2014 (Archived.)
Program Number
RFA-FD-14-015 Federal Agency/Office
Agency: Department of Health and Human ServicesOffice: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement Number of Awards Available
1 Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY What is the process for applying and being award this assistance?
Deadlines
06/11/2014 Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements. Who do I contact about this opportunity?
Headquarters Office
Martin BernardGrants Management Specialist
Phone 240-402-7564
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-015.html
E-mail Address
Martin.Bernard@fda.hhs.gov
Financial Information
Obligations
$1,000,000.00 Range and Average of Financial Assistance
Awards range from $950,000.00 to $1,000,000.00
