Posted · FOR-FD-20-027
Dermal Physiologically-Based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-Solvent Following the Application of Generic Dermatological Products
Food and Drug Administration · HHS
CFDA Numbers
93.103
Award Ceiling
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Award Floor
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Expected Awards
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Close Date
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Section I
How to Apply
Program Contact
Shashi Malhotra <br/>Grants Management Specialist
shashi.malhotra@fda.hhs.gov
Section II
Eligibility
Eligible Applicant Types
00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23
Section III
Description
The overall objective of this funding opportunity is to develop an enhanced mechanistic PBPK model for generic dermatological drug products by accounting for the absorption and evaporation of vehicle/co-solvent simultaneously and implementing the effect of these two dynamic processes on the permeation of a drug molecule through skin. The developed model will be utilized to inform decisions on generic dermatological product development, to enhance the understanding of the effect of metamorphosis of dermatological drug products on skin absorption, and to predict the local and systemic exposure of a drug molecule following topical application of dermatological drug products.
Section IV
Key Dates
- Posted
- May 25, 2021
- Archive
- May 26, 2021