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Development of a Universal Bioequivalence Test Method for Topical Drugs using dOFM

Award Number: U01FD005861
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2016
PERIOD OF PERFORMANCE END DATE: 01/31/2022

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Development of a Universal Bioequivalence Test Method for Topical Drugs using dOFM - PROJECT SUMMARY Generic drugs are an attractive alternative for patients relative to reference listed drugs because generic drugs have the same treatment effect but are generally available at considerably lower costs. However, only a limited number of generic alternatives are available for topically applied dermatological drug products. One of the main reasons for this limitation is the requirement to demonstrate bioequivalence (BE) of the generic and the reference listed drug which is usually achieved by expensive and time-consuming clinical endpoint studies. Hence, there is an urgent need for more cost- and time-efficient, accurate, sensitive and reproducible methods that measure drug concentrations in-vivo in the skin. The current project application “BE-TWO” builds on the completed US FDA co-funded project “dOFM4BE” (2013- 2015) in which dOFM has demonstrated its successful application to assess BE and non-BE of topically applied hydrophilic creams. The new proposed project “BE-TWO” addresses the need for more effective methods to assess BE of topical drugs based on in-vivo dermal pharmacokinetics. “BE-TWO” will develop a general clinical dOFM set-up and a BE test for lipophilic and protein bound substances and establish dOFM as a reliable and easy-to-use method to accurately, sensitively and reproducibly measure BE of any topical dermatological product. To achieve this objective BE-TWO will (1) identify and evaluate factors which influence dOFM data variability for a hydrophilic API based on existing data from project “dOFM4BE”, (2) identify and evaluate additional factors that potentially influence dOFM data variability by conducting a clinical study for lipophilic and protein-bound APIs, and (3) develop strategies to eliminate or minimize influencing factors in order to develop a highly standardized, generally applicable BE test method for all types of APIs which will be tested in a proof-of-concept study.


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: 2022 ( Subtotal = $0 )
2022	2018	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK			AUT	Food and Drug Administration Research	000	3	6/16/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK			AUT	Food and Drug Administration Research	000	3	2/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	000	3	10/23/2018	NON-COMPETING CONTINUATION	$0
2019	2018	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	001	3	8/9/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	001	3	8/16/2018	NON-COMPETING CONTINUATION	$1,000,000
2018	2017	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	000	2	12/5/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,000,000

Issue Date FY: 2017 ( Subtotal = $500,000 )
2017	2017	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	000	2	8/24/2017	NON-COMPETING CONTINUATION	$500,000
														Subtotal = $500,000

Issue Date FY: 2016 ( Subtotal = $500,000 )
2016	2016	Joanneum Research	Elisabethstrasse 5	Graz				AUT	Food and Drug Administration Research	000	1	9/14/2016	NEW	$500,000
														Subtotal = $500,000

Grand Total All Awards = $2,000,000

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Development of a Universal Bioequivalence Test Method for Topical Drugs using dOFM

Award Number: U01FD005861

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2016

PERIOD OF PERFORMANCE END DATE: 01/31/2022

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