Lack of toxicological influences by microsampling (50 µL) from jugular vein of rats in a collaborative 28-day study
| Autor: | Hideaki Yokoyama, Eiji Murata, Fumihiro Jinno, Harumi Kitaura, Atsushi Iwai, Yoshiro Saito, Kyotaka Muta, Norimichi Hattori, Kosuke Saito, Kanae Mori, Hirohiko Ohtsuka, Akio Kobayashi, Asuka Takumi, Keiko Nakai |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
Time Factors Food consumption Physiology In Vitro Techniques 010501 environmental sciences Toxicology Body weight 030226 pharmacology & pharmacy 01 natural sciences Rats Sprague-Dawley 03 medical and health sciences 0302 clinical medicine Jugular vein Toxicity Tests medicine Animals Vein 0105 earth and related environmental sciences Blood Specimen Collection Tail vein Toxicokinetics medicine.anatomical_structure Toxicity Female Animal studies Jugular Veins |
| Zdroj: | The Journal of Toxicological Sciences. 45:319-325 |
| ISSN: | 1880-3989 0388-1350 |
| Popis: | 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 observed in females (14/18 parameters) than in males (6/18), suggesting the possibility that female rats were more susceptible to treatment-based influences. The current results indicate that serial 50 μL sampling from the jugular vein of SD rats had no or very slight toxicological effects, suggesting that this microsampling condition is applicable for toxicokinetic evaluation of non-clinical rat toxicity studies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|