Closed · FOR-FD-20-014 · CFDA 93.103 · Discretionary
PBPK Models to Aid the Development of Generic Dermatological Products
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- Varies
- Award range
- Closed
- Status
- -
- Close date
- -
- Expected awards
The verdict
PBPK Models to Aid the Development of Generic Dermatological Products is a closed discretionary listing from Food and Drug Administration that offered Varies by applicant. Future funding cycles may be published under the same CFDA number.
- Varies
- award range
- Closed
- application status
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - PBPK Models to Aid the Development of Generic Dermatological Products - is cataloged under number FOR-FD-20-014 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as closed, first posted on May 25, 2021. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is Varies by applicant. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity is closed. Monitoring the parent program page is the most reliable way to catch re-announcements in the next funding cycle. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Varies by applicant
Close Date
Not specified
Archiving forecast
Posted
May 25, 2021
Instrument
Cooperative Agreement
Description
PBPK modeling and simulation tools have been extremely useful tool in the drug development process, in the interaction with regulatory agencies, and in decision making in the clinical setting. The objective of this NOFO is to promote further enhancements to improve the predictive power of these modeling and simulation tools and to expand their capabilities in leveraging observed data collected in vivo and in vitro data towards model development and validation. Goals of this research could include:1) Incorporation of formulation attributes such as a. viscosity impacting drug release and stratum corneum permeation, b. Q1/Q2 information leveraged to predict evaporation profiles based on Q2 component) to improve the predictive power of the existing modeling tools.2) Incorporation of new or modification of existing formulation attributes that would allow predicting skin permeation for drug products with unique drug release technologies such as microneedles or iontophoresis3) Development of an in silico in vitro permeation testing module that may support formulation development strategies, formulation selection, inform in vivo PBPK model development by leveraging experimental IVPT data and conduct BE assessments between R and T drug products. Further leverage this module to design IVPT studies that may be clinically relevant and discriminatory at the same time.4) Incorporation of novel approaches in accounting for excipient effects on skin permeation which may include parallel permeation for both API and excipient or identifying excipient-impacted permeation parameters for the API.5) Enhancements of skin physiology models to include skin metabolism with metabolite tracking (develop novel methodologies), enhancements on stratum corneum morphology such as protein binding, and corneocyte dimensions intended to improve prediction for lipophilic compounds).6) Generation of new experimental data as appropriate to support the other goals
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 21, 22, 23. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Shashi Malhotra Grants Management Specialist
Key Dates
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| Sources | the SAM.gov Assistance Listings and Grants.gov |