Potency, efficacy og safety av vaksine X
Etterevaluering
Forsøket vil være opp til betydelig belastende.
Begrunnelse for etterevalueringen
The objectives set in the application were achieved and no other were reached.
The data gathered from the experiment will be used to confirm the safety and potency of the vaccines for registration of a new pharmaceutical product on the market.
Fewer fish were in the category "severe" due to lower mortality and fewer fish were used in potency testing as one group (of 30 fish) was omitted.
Replacement in these types of trials is not possible.
The total number of fish used was according to regulatory requirements.
Animal welfare was taken into consideration and applied via: The use of anesthesia was used when marking and vaccinating the fish.
Humane endpoints were applied during the study.
For potency testing no challenge method was required, as serological testing was conducted to assess the protection of the vaccines.
The data gathered from the experiment will be used to confirm the safety and potency of the vaccines for registration of a new pharmaceutical product on the market.
Fewer fish were in the category "severe" due to lower mortality and fewer fish were used in potency testing as one group (of 30 fish) was omitted.
Replacement in these types of trials is not possible.
The total number of fish used was according to regulatory requirements.
Animal welfare was taken into consideration and applied via: The use of anesthesia was used when marking and vaccinating the fish.
Humane endpoints were applied during the study.
For potency testing no challenge method was required, as serological testing was conducted to assess the protection of the vaccines.