Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01)

Post Date

March 24th 2015

Application Due Date

May 29th 2015

Funding Opportunity Number

RFA-FD-15-032

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

Eligibility Categories

Other

Only the following organization is eligible to apply: UNIVERSITY OF FLORIDA

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $250000

Grant Description

The primary objective of original RFA-FD-14-011 (subtopic 2) is to develop pharmacometric modeling and simulation tools for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. The scope of the awarded study is being expanded to risk-based methodology on generic equivalents of the reference list drugs (RLDs) that may be most susceptible to Яwith causeН switching issues (e.g., modified release oral dosage formsН or Яpatient perceptionН of switching issues where differences in efficacy or safety can be readily perceived in clinical practice (e.g., anticoagulants). The risk-based methodology will be applied to predict which generic product is most likely to encounter switching issues, and least likely to demonstrate post-marketing bioinequivalence.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist
  

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov