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Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations

Award Number: U01FD006700
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations - Abstract The focus of this application is, to understand the impact of compositional differences in topical formulations, on their physical and structural attributes, and in turn, on a patient's perception, which may be linked to therapeutic effect. Additionally, the impact of product ageing on critical Q3 attributes that may in turn affect perception will be investigated through sensorial trials. Prior to this renewal opportunity, we have manufactured 26 gels with different amounts of HEC and CBP used a polymeric gelling agents. Further Q2 differences were introduced by varying propylene glycol and alcohol content, systematically. These products were extensively characterized for a range of Q3 parameters that relate to key sensorial perceptions. As a part of this project renewal, we will start sensorial focus group evaluations. We have been successful at gaining ethics approval from our local IRB and a non-involvement status from FDA, in readiness for the trials. An additional new dimension included in this renewal is, testing the product quality/structural attributes as well as sensory attributes on different topical products at predetermined time points during a product’s shelf life. We have developed instrumental techniques with robustly designed methods as a part of our current work, which can be used to predict patient perception/acceptance. These tests once compared against sensory panel test and validated could potentially replace sensory panel testing. This would be immensely beneficial to the industry.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	THE UNIVERSITY OF QUEENSLAND	THE UNIVERSITY OF QUEENSLAND	ST LUCIA				AUS	Food and Drug Administration Research	000	4	9/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	THE UNIVERSITY OF QUEENSLAND	THE UNIVERSITY OF QUEENSLAND	ST LUCIA				AUS	Food and Drug Administration Research	000	4	4/7/2023	NON-COMPETING CONTINUATION	$0
2023	2022	THE UNIVERSITY OF QUEENSLAND	THE UNIVERSITY OF QUEENSLAND	ST LUCIA				AUS	Food and Drug Administration Research	001	4	8/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $250,000 )
2022	2022	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	005	4	7/22/2022	NON-COMPETING CONTINUATION	$250,000
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	004	3	2/9/2022	COMPETING CONTINUATION	$0
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	003	3	1/31/2022	COMPETING CONTINUATION	$527,180
2022	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	000	3	11/23/2021	COMPETING CONTINUATION	$0
2022	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	002	2	1/31/2022	NON-COMPETING CONTINUATION	-$499,990
2022	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	001	1	1/31/2022	NEW	-$27,190
														Subtotal = $250,000

Issue Date FY: 2021 ( Subtotal = $250,000 )
2021	2021	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	001	3	7/14/2021	COMPETING CONTINUATION	$250,000
2021	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	000	2	12/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $250,000

Issue Date FY: 2020 ( Subtotal = $499,990 )
2020	2020	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	002	2	8/5/2020	NON-COMPETING CONTINUATION	$499,990
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	001	1	3/13/2020	NEW	$0
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	11/6/2019	NEW	$0
														Subtotal = $499,990

Issue Date FY: 2019 ( Subtotal = $250,000 )
2019	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	8/20/2019	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $1,249,990

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Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations

Award Number: U01FD006700

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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