Opportunity ID: 327603
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-20-014 |
| Funding Opportunity Title: | PBPK Models to Aid the Development of Generic Dermatological Products |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments For profit organizations other than small businesses Individuals Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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 iontophoresis 3) 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 |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Packages
Share This Post, Choose Your Platform!
About the Author: osnqt
