Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01)
The summary for the Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) grant is detailed below.
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Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01): 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 “with cause” switching issues (e.g., modified release oral dosage forms” or “patient perception” 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.
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 “with cause” switching issues (e.g., modified release oral dosage forms” or “patient perception” 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.
Federal Grant Title: | Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) |
Federal Agency Name: | Food Drug Administration |
Grant Categories: | Consumer Protection Food and Nutrition Health |
Type of Opportunity: | Mandatory |
Funding Opportunity Number: | RFA-FD-15-032 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | May 29, 2015 |
Original Application Deadline: | May 29, 2015 |
Posted Date: | Mar 24, 2015 |
Creation Date: | Mar 24, 2015 |
Archive Date: | Jun 28, 2015 |
Total Program Funding: | $250,000 |
Maximum Federal Grant Award: | $250,000 |
Minimum Federal Grant Award: | none |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Additional Information on Eligibility
- Only the following organization is eligible to apply: UNIVERSITY OF FLORIDA
- Grant Announcement Contact
- Lisa Ko
Grants Management Specialist
[email protected]
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