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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

Award Floor

Expected Awards

Close Date

Section I

How to Apply

View on grants_gov ↗

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