Investigation of residue depletion after administration of a new pharmaceutical product in the feed in Atlantic salmon smolts prior to transfer to small-scale sea cages in Northern Norway
1 Purpose
Assess tissue depletion rates and safety aspects of a chemotherapeutic agent for use in salmon in a mini cage trial unit.
2 Distress
Slight. The principal causes of distress in the trial are transportation to sea and sampling during the sea phase. No treatment-related harm is expected to be caused to the fish that are given the medicated feed; a significant volume of study data has reported no treatment-related adverse effects following oral administration of the target dose of the active ingredient. Two specific safety studies have further indicated a high safety margin; the product was well tolerated in Atlantic salmon after oral treatment at up to five times the recommended dose, for three times the duration.
3 Expected benefit
Potentially high. Sea lice are one of the major challenges in the Norwegian salmon industry. Major efforts are made to prevent and treat the infestation but more methods are needed. The purpose of the present trial is to gain further knowledge of a new potential veterinary pharmaceutical product for the Norwegian market that provides a new tool in the toolbox in the fight against sea lice. In particular, the present study will provide data on residue levels of the product in the fillet of the salmon to help determine the withdrawal period under Norwegian conditions i.e. the minimum time after administration where the fish can be slaughtered for human consumption. These data are pivotal for the future granting of a Norwegian marketing authorization for the product.
4 Number of animals, and what kind
In this study, a total of 1000 juvenile Atlantic salmon will be administered the product as an in-feed treatment at the hatchery. Treated fish will later be transferred to a marine farm site where they will continue to grow and be evaluated under the study for one year. The number of animals to be treated has been determined based on the capacity of the facilities at the study site. By selecting this number of fish, we expect to be able to replicate, under controlled conditions, the husbandry conditions under which these fish will be reared. The number of fish to be sampled for fillet sample collection has been determined based on the official guidelines and in alignment with the Norwegian Medicines Agency.
5 How to adhere to 3R
The number of animals to be treated has been determined based on the capacity of the facilities at the study site. By selecting this number of fish, we expect to be able to replicate, under controlled conditions, the husbandry conditions under which these fish will be reared. The number of fish to be sampled for fillet sample collection has been determined based on the official guidelines and in alignment with the Norwegian Medicines Agency.
Assess tissue depletion rates and safety aspects of a chemotherapeutic agent for use in salmon in a mini cage trial unit.
2 Distress
Slight. The principal causes of distress in the trial are transportation to sea and sampling during the sea phase. No treatment-related harm is expected to be caused to the fish that are given the medicated feed; a significant volume of study data has reported no treatment-related adverse effects following oral administration of the target dose of the active ingredient. Two specific safety studies have further indicated a high safety margin; the product was well tolerated in Atlantic salmon after oral treatment at up to five times the recommended dose, for three times the duration.
3 Expected benefit
Potentially high. Sea lice are one of the major challenges in the Norwegian salmon industry. Major efforts are made to prevent and treat the infestation but more methods are needed. The purpose of the present trial is to gain further knowledge of a new potential veterinary pharmaceutical product for the Norwegian market that provides a new tool in the toolbox in the fight against sea lice. In particular, the present study will provide data on residue levels of the product in the fillet of the salmon to help determine the withdrawal period under Norwegian conditions i.e. the minimum time after administration where the fish can be slaughtered for human consumption. These data are pivotal for the future granting of a Norwegian marketing authorization for the product.
4 Number of animals, and what kind
In this study, a total of 1000 juvenile Atlantic salmon will be administered the product as an in-feed treatment at the hatchery. Treated fish will later be transferred to a marine farm site where they will continue to grow and be evaluated under the study for one year. The number of animals to be treated has been determined based on the capacity of the facilities at the study site. By selecting this number of fish, we expect to be able to replicate, under controlled conditions, the husbandry conditions under which these fish will be reared. The number of fish to be sampled for fillet sample collection has been determined based on the official guidelines and in alignment with the Norwegian Medicines Agency.
5 How to adhere to 3R
The number of animals to be treated has been determined based on the capacity of the facilities at the study site. By selecting this number of fish, we expect to be able to replicate, under controlled conditions, the husbandry conditions under which these fish will be reared. The number of fish to be sampled for fillet sample collection has been determined based on the official guidelines and in alignment with the Norwegian Medicines Agency.