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Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time.
Accidental exposure of these products to alcohol can result in the relatively rapid
release of large quantities of drug with severe side effects, including death.
To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products.
To date, ADD assessments have not been harmonized globally.
For instance, the U. S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media.
This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations.
In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior.
The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.
Accidental exposure of these products to alcohol can result in the relatively rapid
release of large quantities of drug with severe side effects, including death.
To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products.
To date, ADD assessments have not been harmonized globally.
For instance, the U. S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media.
This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations.
In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior.
The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $250,000
Office: Food and Drug Administration
Estimated Funding: $250,000
Who's Eligible
Obtain Full Opportunity Text:
http://Click on Application Tab above to download full announcement instructions and application package.
Additional Information of Eligibility:
All types of domestic applicants are eligible to apply, except nonprofit organizations described in section 501(c)(4) of the Internal Revenue Code of 1986 that engaged in lobbying activities after December 31, 1995.
Federally affiliated entities must adhere to the eligibility standards below: III.A.1.
DOE/NNSA National Laboratories DOE/NNSA National Laboratories are eligible to submit applications (either as a lead organization or as a team member in a multi-institutional team) under this FOA and may be proposed as subrecipients under another organization’s application.
If recommended for funding as a lead applicant or a team member, funding will be provided through the DOE Field-Work Proposal System and work will be conducted under the laboratory’s contract with DOE.
No administrative provisions of this FOA will apply to the laboratory or any laboratory subcontractor.
If recommended for funding as a proposed subrecipient, the value of the proposed subaward will be removed from the prime applicant’s award and will be provided to the laboratory through the DOE Field-Work Proposal System and work will be conducted under the laboratory’s contract with DOE.
Additional instructions for securing authorization from the cognizant Contracting Officer are found in Section VIII of this FOA.
III.A.2.
Non-DOE/NNSA FFRDCs Non-DOE/NNSA FFRDCs are eligible to submit applications (either as a lead organization or as a team member in a multi-institutional team) under this FOA and may be proposed as subrecipients under another organization’s application.
If recommended for funding as a lead applicant or a team member, funding will be provided through an interagency agreement Award to the FFRDC’s sponsoring Federal Agency.
If recommended for funding as a proposed subrecipient, the value of the proposed subaward may be removed from the prime applicant’s award and may be provided through an Inter-Agency Award to the FFRDC’s sponsoring Federal Agency.
Additional instructions for securing authorization from the cognizant Contracting Officer are found in Section VIII of this FOA.
III.A.3.
Other Federal Agencies Other Federal Agencies are eligible to submit applications (either as a lead organization or as a team member in a multi-institutional team) under this FOA and may be proposed as subrecipients under another organization’s application.
If recommended for funding as a lead applicant or a team member, funding will be provided through an interagency agreement.
If recommended for funding as a proposed subrecipient, the value of the proposed subaward may be removed from the prime applicant’s award and may be provided through an interagency agreement.
Additional instructions for providing statutory authorization are found in Section VIII of this FOA.
Full Opportunity Web Address:
http://Click on Application Tab above to download full announcement instructions and application package.
Contact:
Agency Email Description:
terrin.brown@fda.hhs.gov
Agency Email:
Date Posted:
2024-01-15
Application Due Date:
Archive Date:
2024-04-30
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