Progress 05/01/05 to 04/30/08
Outputs
OUTPUTS: Florfenicol in Sheep for respiratory disease (ADR #325): All FDA/CVM required studies for this project have been completed. The manufacturer of this product changed the formulation and we are waiting for an update regarding the status of this product. Progesterone CIDRs (Controlled Internal Drug Release Devices) in Goats for estrous synchronization (ADR #324): The target animal safety study and report have been accepted by FDA/CVM (February 2008). The milk residue study has been completed and the data sent to UC Davis for review. FDA/CVM has provided comments regarding the efficacy protocol and the revision is underway. Fish species grouping: The sample analysis for florfenicol is complete. Erythromycin in salmonids (ADR# 135): The environmental assessment was sent to FDA/CVM for review and they have requested a revision of certain sections and a chronic toxicity study with Daphnia magna which will address CVM concerns regarding chronic toxicity to aquatic insects. Other studies will include a study to identify physico-chemical properties of erythromycin and a study to determine the microbial toxicity of various erythromycin transformation products. Lincomycin soluble powder for foulbrood disease in honeybees (ADR #311): Currently waiting for the data summary for CVM submission. Tulathromycin in goats (ADR #340) (collaborative project with the North Central Region): The quality assurance was performed for the target animal safety study in February and March 2008. The LC/MS installation has been completed and the laboratory director is currently working on establishing approved analytical methods. Excede in goats: We have completed this study in non-lactating goats and the portion of the study in lactating goats should be completed in June 2008. PARTICIPANTS: No Participant information reported. TARGET AUDIENCES: Veterinarians and commodity groups. PROJECT MODIFICATIONS: No Project Modifications information reported.
Impacts
Pharmacokinetics, human food safety, and target animal safety studies are required by FDA/CVM to obtain minor and specialty animal drug clearances in minor species for drug registration. Data must be obtained for each animal species for which drug use is intended. These minor use animal drug registrations will impact the farmers and ranchers of the Western Region with the potential beneficiaries of this research being the consumers in the Western Region and the rest of the United States.
Publications
- No publications reported this period
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Progress 05/01/06 to 05/01/07
Outputs
Florfenicol in Sheep for respiratory disease (ADR #325): This report required additional data. The MIC data was accepted for publication in the Journal of the American Veterinary Medical Association. The Tissue Residue results were presented at the 10th European Association for Veterinary Pharmacology and Toxicology (EAVPT) meeting in Turin, Italy. Progesterone CIDRs in Sheep for estrous synchronization (ADR #258): The target animal safety portion was completed and the final report has been accepted by FDA/CVM. Progesterone CIDRs in Goats for estrous synchronization (ADR #324): The Target Animal Safety report has been received and is currently undergoing Quality Assurance review. The milk residue and human food safety studies are being planned for 2007. Species Grouping: The work on the in vitro and in vivo studies have been completed. A paper on the first portion of the in vitro modeling was accepted for publication in the Journal of Veterinary Pharmacology and
Therapeutics. Whole animal studies have been run in all species for serum pharmacokinetics of midazolam, the CYP3 marker substrate. Our Staff Research Associate has worked out a method for extracting the parent midazolam and metabolites from tissues and has analyzed over 1000 liver, muscle, and fat samples. The PBPK modeling was finished using these tissue data.
Impacts
Pharmacokinetics, human food safety, and target animal safety studies are required by FDA/CVM to obtain minor and specialty animal drug clearances in minor species for drug registration. Data must be obtained for each animal species for which drug use is intended. These minor use animal drug registrations will impact the farmers and ranchers of the Western Region with the potential beneficiaries of this research being consumers in the Western Region and the rest of the United States.
Publications
- Cortright, K.A. and Craigmill, A.L. Cytochrome P450-dependent metabolism of midazolam in hepatic microsomes from chickens, turkeys, pheasant and bobwhite quail. J Vet Pharmacol Therap 29(6)469-476, 2006.
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Progress 05/01/05 to 04/30/06
Outputs
ADR#325 - Florfenicol for sheep for respiratory disease. The MIC technical report is complete and under review. The human food safety portion is under Quality Assurance review. ADR#324 - Progesterone CIDRs for Goats. A product development conference call was conducted in August and agreement reached on what needed to be in the protocols for efficacy, target animal safety (TAS) and human food safety. The TAS study began on September 7, 2005 and is complete. We are awaiting the report from the principal investigator. Species Grouping: A paper has been submitted on the first portion of the in vitro modeling to JVPT. The PBPK model for the birds will be accomplished during the summer of 2006. Whole animal studies have been run in all species for serum pharmacokinetics of midazolam, the CYP3 marker substrate. Tissue analysis will take much longer to complete so that we can validate the PBPK model with the inclusion of the in vitro data. We are looking for a rapid LC-MS
assay to facilitate the tissue analysis, and hope to complete this project by the fall of 2006.
Impacts
Pharmacokinetics, human food safety, and target animal safety studies are required by FDA/CVM to obtain minor and specialty animal drug clearances in minor species for drug registration. Data must be obtained for each animal species for which drug use is intended. These minor use animal drug registrations will impact the farmers and ranchers of the Western Region with the potential beneficiaries of this research being consumers in the Western Region and the rest of the United States.
Publications
- Cortright, K.A. and Craigmill, A.L. In Vitro and In Vivo Kinetics of Midazolam in Commercially Raised Gamebirds (Abstract) 44th Annual Meeting of the Society of Toxicology, #1561, 2005.
- Cortright, K.A. and Craigmill, A.L. Cytochrome P450-dependent Metabolism of Midazolam in Hepatic Microsomes from Chickens, Turkeys, Pheasants, and Bobwhite Quail. JVPT, In Press, 2006.
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