Traduction de «Sacrifice en cours d'essai » (Français → Anglais) :

Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, for example when the clinical trial is still ongoing in third countries and data from that part of the trial are not available, which makes a statistical analysis not relevant, the sponsor should justify this in the protocol and specify when the results are going to be submitted.

Dosing should continue during the 2-week mating period and, for P females, throughout gestation and lactation up to the day of termination after weaning. Males should be treated in the same manner until termination at the time when the F1 animals are weaned.

If the primary antibody response is assayed by counting plaque-forming cells, it is permissible to evaluate subgroups of animals on separate days, provided that: subgroup immunisation and sacrifice are timed so that PFCs are counted at the peak of the response; that subgroups contain an equal number of male and female offspring from all dose groups, including controls; and that subgroups are evaluated at approximately the same po ...[+++]stnatal age.Exposure to the test chemical will continue until the day before collecting spleens for the PFC response or serum for the ELISA assay.

if the force measured when the required energy level has been reached in the various horizontal load tests does not deviate from the force measured when the required energy has been reached in the original test by more than ± 7 % and the deflection measured (4) when the required energy level has been reached in the various horizontal load tests does not deviate from the deflection measured when the required energy has been reached in the original test by more than ± 7 % (in case of a static test).

In this case, the test shall be carried out until consistency of production and correlation with appropriate in process controls have been established and thereafter compensated by appropriate in-process controls.

However, after the removal of the load, the structure shall not enter the zone of clearance, which shall be completely protected.1.7.Crushing testIf cracks or tears which cannot be considered as negligible appear during a crushing test, a second, similar crushing, but with a force of 1,2 Fv, shall be applied immediately after the crushing which caused the cracks or tears to appear.2.ZONE OF CLEARANCEThe zone of clearance is identical to that described in Item 2 of Annex III A above, except that the word 'impact' is to be replaced by 'load' in the last line of Item 2.2.10.3.MEASUREMENTS TO BE MADE3.1.Fractures and cracksAfter each test all structural members, joints and attachment systems shall be visually examined for fractures or cracks, ...[+++] any small cracks in unimportant parts being ignored.3.2.Zone of clearance3.2.1.During each test an examination shall be made to see whether any part of the protection structure has entered the zone of clearance as defined in Item 2 above.3.2.2.In addition, an examination shall be made to determine whether any part of the zone of clearance is outside the protection of the protection structure.