Notice of Intent to Publish a Funding Opportunity Announcement for Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-Gastrointestinally Absorbed Drug Products in Humans (U01)

Notice Number: NOT-FD-14-003

Key Dates
Release Date: February 24, 2014

Related Announcements
None

Issued by
Food and Drug Administration (FDA)

Purpose

This Notice is to inform potential applicants of the Food and Drug Administration (FDA) intent to publish a Funding Opportunity Announcement (FOA) for physiologically based absorption and pharmacokinetic modeling and simulation for non-gastrointestinally absorbed drug products in humans, allow potential applicants sufficient time to develop meaningful collaborations and responsive projects and encourages teams with complementary expertise in the physiologically based modeling and simulation experience to apply for this new FOA.

Proposed applications will develop physiologically based absorption and pharmacokinetic models to facilitate generic drug product guidance preparation, development of generic formulations by industry, and generic drug product evaluation in the following subtopics:

1. Physiologically based pharmacokinetic modeling and simulation of dermal absorption;
2. Physiologically based pharmacokinetic modeling and simulation of ocular absorption;
3. Physiologically based pharmacokinetic modeling and simulation for complex parenteral drug products (including liposomes, nanosuspension, micelles, microspheres, implants, and hydrogels); 3. 4. Physiologically based pharmacokinetic modeling and simulation of lung absorption via oral inhalation;
4. Physiologically based pharmacokinetic modeling and simulation of absorption from nasally delivered products (including nasal solutions, suspensions as well as nasal insufflation as a potential route of abuse).

Each applicant may apply to one or more of the subtopics listed above. Applicants applying for more than one subtopic must prepare separate applications for each subtopic.

The anticipated application due date is May 2014. Applications for this FOA will be electronic and be submitted through the Grants.gov.  Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Xinyuan Zhang
Food and Drug Administration
Center for Drug Evaluation and Research/ Office of Generic Drugs
Telephone: 240-276-8615
Email: Xinyuan.Zhang@fda.hhs.gov

 

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