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Development of Predictive in vitro Methods for Characterizing Product Performance, using , Case Study: Furosemide

Award Number: U01FD005307
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2016

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Development of Predictive in vitro Methods for Characterizing Product Performance, using , Case Study: Furosemide - RFA-FD-14-080: Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide Project Summary / Abstract: The overall aim of the current grant application is to develop in vitro models that can predict drug performance in the pediatric patient. This will be achieved in an iterative process. First a throughout review of the gastro-intestinal physiology of the pediatric patient will be carried out. Then, based on this, a range of physiologically relevant media, simulating the pediatric gastric and intestinal fluids, will be composed. These will also include typically infant meals, such as milk, baby formula and Ensure Plus. The media will be used in modified compendial dissolution apparatuses, adjusted eg with regard to volume, to better simulate the pediatric patient. In addition, models closer simulating the gastro- intestinal physiology, eg the Dynamic Gastric Model will be employed. Data obtained will be compared to available in vivo data, and the models modified as to optimize the prediction of the in vivo performance. Finally, the data will be used in the development of physiologically based pharmacokinetic models. The project will therefore increase the current knowledge and understanding of the performance of poorly soluble drugs in the pediatric population and as such provide a basis for better formulations and thereby also an improved dosing regime for the better of the pediatric patient.


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: 2018 ( Subtotal = $0 )
2018	2015	KOBENHAVNS UNIVERSITET	NORREGADE 10	KOBENHAVN K		1165		DNK	Food and Drug Administration Research	000	2	1/12/2018	NON-COMPETING CONTINUATION	$0
2018	2015	KOBENHAVNS UNIVERSITET	NORREGADE 10	KOBENHAVN K		1165		DNK	Food and Drug Administration Research	001	2	1/16/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = -$50,000 )
2017	2015	KOBENHAVNS UNIVERSITET	NORREGADE 10	KOBENHAVN K		1165		DNK	Food and Drug Administration Research	000	2	1/19/2017	NON-COMPETING CONTINUATION	-$50,000
														Subtotal = -$50,000

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2015	University of Copenhagen	Norregade 10	COPENHAGEN		1165		DNK	Food and Drug Administration Research	000	2	2/8/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $50,000 )
2015	2015	University of Copenhagen	Norregade 10	Copenhagen				DNK	Food and Drug Administration Research	000	2	8/3/2015	NON-COMPETING CONTINUATION	$50,000
														Subtotal = $50,000

Issue Date FY: 2014 ( Subtotal = $99,895 )
2014	2014	University of Copenhagen	Norregade 10	Copenhagen				DNK	Food and Drug Administration Research	000	1	9/10/2014	NEW	$99,895
														Subtotal = $99,895

Grand Total All Awards = $99,895

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Development of Predictive in vitro Methods for Characterizing Product Performance, using , Case Study: Furosemide

Award Number: U01FD005307

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2016

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