Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (U01)

Post Date

April 29th 2014

Application Due Date

June 11th 2014

Funding Opportunity Number

RFA-FD-14-015

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Health
Science and Technology and other Research and Development

Number of Awards

1

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other
Unrestricted

FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY

Funding

• Estimated Total Funding:

  $1000000

• Award Range:

  $950000 - $1000000

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Martin Bernard
  Grants Management Specialist
  Phone 240-402-7564

• Agency Mailing Address:

  FDA OFFICE

• Agency Email Address:

  Martin.Bernard@fda.hhs.gov

• More Information:

  FULL ANNOUNCEMENT