The animals were monitored daily for weight loss and clinical signs of EAE, which was scored according to the following scheme: 0: healthy; 0.5: partial loss of tail tonus; 1: complete loss of tail tonus; 2: hind limb weakness, unsteady gait; 3: hind limb paralysis (this was for ethical reasons set as endpoint for EAE experiments).
MDR was calculated from non-censored EC50 values of the four endpoints Daphnia and fish acute toxicity as well as algal and Lemna growth inhibition (total n = 274) based on the data set compiling endpoints for the individual compounds as similar as possible to those used for the products.
Serum AST and ALT levels were assessed by using commercial kits (Roche Diagnostics, GmbH, D-68298, Mannheim, Germany) in Roche-Hitachi Modular Autoanalyzer (Roche Diagnostics, GmbH, D-68298, Mannheim, Germany).Bayer Opera autoanalyzer was used to measure bilirubin levels by wavelength, 550 nm; temperature, 37°C; and instrument set for endpoint with sample blanking mode.
Analysis set for secondary endpoints: All patients will be included for analysis for secondary endpoints treated at least one with the study treatment.
The Analysis set for primary endpoint consists of all patients treated at least once with the study treatment.
9– 11 The Assessments in Ankylosing Spondylitis International Society ASASS), which published a core set of endpoints for the disease more than 10 years ago 12 has taken the lead in developing recommendations for anti-tumour necrosis factor (TNF) therapy in ankylosing spondylitis (AS), 13 which have already been updated twice.
The Routine Assessment of Patient Index Data (RAPID) and the Patient Activity Scale (PAS) are patient self-report questionnaires consisting of the three patient-reported outcomes of the core set of endpoints for RA clinical trials: pain, patient global assessment of disease activity, and the Health Assessment Questionnaire HAQQ) [ 9, 10].
Feeding rates and reproduction of D. magna submitted to combined exposures of ultraviolet radiation and carbendazim showed a dose-ratio deviation from the conceptual model as the best description of the data set, for both endpoints.
Since trigger values have not yet been set for these endpoints, a WoE approach is needed to decide on a case-by-case basis whether a substance fulfils the T criterion as part of PBT assessment.
In the simulated-use study 100% of the Olympus colonoscopes, duodenoscopes and bronchoscopes evaluated met or surpassed the cleaning endpoints set for protein, and bioburden residuals (hemoglobin was not evaluated).
