Lack of toxicological influences by microsampling (50 µL) from jugular vein of rats in a collaborative 28-day study.

Lack of toxicological influences by microsampling (50 µL) from jugular vein of rats in a collaborative 28-day study. J Toxicol Sci. 2020;45(6):319-325 Authors: Yokoyama H, Hattori N, Ohtsuka H, Murata E, Kobayashi A, Muta K, Takumi A, Kitaura H, Jinno F, Iwai A, Nakai K, Mori K, Saito K, Saito Y Abstract Due to finalization of the ICH S3A Q&A focusing on microsampling, application of microsampling technique to regular non-clinical animal studies is expected for non-clinical safety assessment of pharmaceuticals. In Europe, microsampling from the tail vein or saphenous vein has often been used, whereas sampling from the jugular vein is thought to be more common for non-clinical studies in Japan. Therefore, we assessed the toxicological effects of serial microsampling from the jugular vein of SD rats in a common 28-day study at 4 independent organizations. Fifty microliter sampling was performed at 6 timepoints on day 1 to 2 and 7 timepoints on day 27 to 28 and its toxicological influences on body weight, food consumption, hematological and clinical chemistry parameters, and organ weights (on day 29 for 3 and day 28 for 1 organizations) were evaluated. The serial microsampling was shown to have no or minimal influences on the assessed parameters. The observed statistical differences for the 18 parameters were sporadic and did not appear to be systemically associated with microsampling. However, the sporadic changes were more often ...
Source: Journal of Toxicological Sciences - Category: Toxicology Tags: J Toxicol Sci Source Type: research