Drug Approval Research on 17α-Methyltestosterone

September 1, 2009 - August 31, 2010

Chaired by Rosalie A. Schnick, National Aquaculture NADA Coordinator, Michigan State University.

There are two sub-projects for this funded project:

Project #1: Official Transfer of 17 α-methyltestosterone (MT) Analytical Method for Feed

Develop study protocols to conduct the MT feed method transfer of the MT analytical feed method.
Submit method transfer study protocols to the Center for Veterinary Medicine (CVM) for concurrence.
Provide final study protocols to participating laboratories.
Prepare and ship medicated feed to participating laboratories.
Assay control and medicated feed samples according to the study protocols concurred with by CVM.
Complete report of analysis and submit along with raw data to the Upper Midwest Environmental Sciences Center (UMESC).
Compare and discuss the results of both the CANTEST, Ltd. (CANTEST) reference (expert) and transferred (naïve) analyses of the MT transfer study samples based on the MT analytical feed method developed by the University of Wisconsin-Madison (UW-Madison).
Determine whether any changes are needed to the MT analytical feed method developed UWMadison based on the results of the MT feed transfer study.
Validate that the naïve analyst at CANTEST can analyze the MT feed samples according to the analytical feed method developed by UW-Madison.
Compile Final Study Report (FSR), archive raw data, and submit FSR to CVM through the UMESC MT investigational new animal drug (INAD) exemption.
Respond to CVM comments.
Gain acceptance from CVM for the MT feed method transfer study.

Project #2: Repeat of the 17"-methyltestosterone Target Animal Safety Study in Tilapia

Interact with CVM to determine whether the study design and protocol developed by Southern Illinois University at Carbondale (SIUC) will need to be modified.
Submit the revised study protocol to CVM for concurrence.
Conduct a target animal safety study using MT on tilapia according to the CVM concurred protocol that is based on the guidelines for a target animal safety study in feed under Good Laboratory Practices (GLP).
Write the FSR and submit to CVM through the Aquatic Animal Drug Approval Partnership Program (AADAP) MT INAD.
Respond to CVM comments.
Gain acceptance from CVM for the target animal safety study on MT in tilapia.

Proposed Budget for Project #1:
Principal Investigator/ Institution	Objectives	Year 1	Total
Mark P. Gaikowski/USGS, Upper Midwest Environmental Sciences Center	1-12	$15,780	$15,780
Nilmini Wijewickreme/ Reference Laboratory, CANTEST Ltd.	1-12	$12,100	$12,100
Nilmini Wijewickreme/ Transferee Laboratory, CANTEST Ltd	1-12	$5,400	$5,400*
		Total	$33,280
Proposed Budget for Project #2:
David L. Straus / USDA/ARS, Harry K. Dupree Stuttgart National Aquaculture Research Center	1-6	$21,335	$21,335*
		Total	$21,335
		Grand Total	$54,615

Project Outline (1.18M pdf file)

Project Number: 9

$27880.00

2008-38500-19157