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Submitted to: Aquatic Animal Drug Approval Partnership (AADAP)
Publication Type: Other Publication Acceptance Date: 3/24/2010 Publication Date: 3/29/2010 Citation: Straus, D.L. 2010. USDA's Corner. Aquatic Animal Drug Approval Partnership (AADAP). 6(1):10-11. Interpretive Summary: Technical Abstract: We have finally received funding for parts of a GLP compliant Target Animal Safety study to evaluate the safety of 17a-methyltestosterone administered in feed to tilapia; we will again be working with the folks at AADAP on this study. A preliminary trial was completed in October/November to establish a larval tilapia growth curve to predict feed amounts to be administered to fish each day of the study. The in-life phase of the 28 day study is tentatively scheduled for May. After the in-life phase, the fish tissues will be sent to AADAP to be processed and evaluated histologically. Our collaborations with AADAP continues to be beneficial for the overall drug approval project and have helped to speed things along. Research continues with the high-density, low-flow columnaris disease method and we have had reliable success in producing columnaris infections in catfish. We are preparing to devote the next few months to our egg fungus studies with various therapeutants, so our columnaris research will continue in the fall. A Final Study Report for the CuSO4 Target Animal Safety study on channel catfish eggs was submitted to FDA/CVM on December 1, 2009. A Final Study Report for the effectiveness range-finding (supportive) studies of CuSO4 on saprolegniasis of channel catfish eggs is written and should be submitted in April; pivotal dose-confirmation reports will follow. Dave Straus, Disease & Drug Approval Section, Harry K. Dupree – Stuttgart National Aquaculture Research Center, Agricultural Research Service, U.S. Dept. of Agriculture, Stuttgart, AR. |
