National Academy of Agricultural Sciences (NAAS)
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PRINT ISSN : 2319-7692
Online ISSN : 2319-7706 Issues : 12 per year Publisher : Excellent Publishers Email : editorijcmas@gmail.com / submit@ijcmas.com Editor-in-chief: Dr.M.Prakash Index Copernicus ICV 2018: 95.39 NAAS RATING 2020: 5.38 |
Preclinical safety evaluation of a biopharmaceutical agent is highly essential to identify and define the toxicity profile of the agent. The present study was carried out on Sprague Dawley rats to evaluate the sub-acute toxicity of an anti - tumor necrosis factor -alpha receptor fusion protein named etanercept. Etanercept is a biopharmaceutical compound and is the first anti-tumor necrosis factor agent to be approved for the treatment of rheumatoid arthritis. To simulate the human intended route, the etanercept was administered through the subcutaneous route for a period of 28 days with a 14 days of recovery period for high dose alone. To evaluate the safety margin in the pre-clinical set-up, the dose levels were selected approximately 1, 5 and 10 times of the human equivalent dose (HED).No morbidity, mortality and clinical signs of toxicity were observed in the animals belonging to the control groups as well as the test substance treated groups throughout the observation period. The in-life data like, body weight gain,feed consumption and water consumption revealed no significant difference in comparison between the treated and their concurrent control animals. Hematology and biochemical examinations did not show significant changes in all the treated groups in comparison with their concurrent control groups. No test substance related changes were observed in absolute and relative organ weights of both the sexes of treated animals. No test substance related gross pathological findings were observed in animals treated with test substance. As the test substance did not produce any significant adverse effect, the high dose i.e. 52mg/kg b.w. was concluded as no-observed-adverse-effect level (NOAEL) for etanercept in the Sprague Dawley rats through subcutaneous route.
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