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Analytical method validation to detect and quantify tulathromycin residues in caprine liver

Award Number: R01FD008143
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/20/2024
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Analytical method validation to detect and quantify tulathromycin residues in caprine liver - PROJECT SUMMARY This project aims to address the significant problem of bacterial pneumonia in goats, which is a major cause of morbidity and mortality and represents a significant welfare challenge for operations in the United States. Currently, there is only one FDA-approved antibiotic for the treatment of respiratory disease in goats, which requires daily administration. That decreases efficacy in situations where owner compliance with labeled instructions is lacking. To address this problem, the proposed research aims to validate an analytical method for the detection and quantification of tulathromycin residues in caprine liver and conduct a freezer stability study of tulathromycin in caprine liver. The expected outcome is to have a validated LC-MS analytical method for the detection and quantification of tulathromycin residues in caprine liver that will be used for completion of the HFS technical section and future studies to determine tulathromycin residue depletion. The label approval of Draxxin® 25 will make it easier for veterinarians to use tulathromycin in goats with confidence in scientifically based labeled slaughter withdrawal times.


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: 2025 ( Subtotal = $0 )
2025	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Food and Drug Administration Research	000	1	10/8/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $205,612 )
2024	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Food and Drug Administration Research	000	1	1/26/2024	NEW	$205,612
														Subtotal = $205,612

Grand Total All Awards = $205,612

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Analytical method validation to detect and quantify tulathromycin residues in caprine liver

Award Number: R01FD008143

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/20/2024

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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