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Approaches of validation of a 2-week combined repeated oral dose toxicity study with plasma micro sampling toxicokinetics (PMS-TK) in common marmosets.
Author: InoueRyo, KouheiYoko, MochizukiHidemi, MurotaNaoya, NiiKazuo, NishimeChiyoko, SatoShin-Ichi, TaniguchiMasahiro, TsutsumiHideki
Original Abstract of the Article :
We investigated the viability of a combined repeated dose toxicity study, including toxicokinetics (TK), in common marmosets according to the ICH-S4, ICH-S3A and ICH-S7A Guidelines using valsartan as test article whose non-clinical repeated dose toxicity studies had been conducted using this species...See full text at original site
Dr.Camel's Paper Summary Blogラクダ博士について
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引用元:
https://doi.org/10.2131/jts.43.685
データ提供:米国国立医学図書館(NLM)
Toxicokinetics in Marmosets: A New Oasis in the Desert of Animal Research
The development of new drugs often involves extensive animal testing to ensure safety and effectiveness. Marmosets, small primates, have become increasingly popular models for preclinical studies. This study explores the feasibility of combining repeated dose toxicity testing with toxicokinetics (TK) analysis, using a plasma micro sampling method, in marmosets. The researchers used valsartan, a drug commonly used to treat high blood pressure, as a test article.
The study, like an expedition across a challenging desert landscape, revealed that a combined repeated dose toxicity study, including TK analysis, is viable in marmosets. The researchers demonstrated that the plasma micro sampling TK method, a powerful new technique, provided valuable insights into the relationship between toxic changes and drug concentrations, while minimizing the number of blood samples required from each animal.
A New Path Forward: Embracing Animal Welfare in Research
The study's findings, like a well-worn path through a previously uncharted desert, open up new possibilities for drug safety testing in marmosets. The researchers have shown that combining repeated dose toxicity with TK analysis, using the plasma micro sampling method, is a viable and humane approach to drug development.
Animal Welfare in Research: A Desert Oasis of Compassion
As Dr. Camel, I am particularly excited by the study's emphasis on animal welfare. Just as a desert oasis provides water and respite for weary travelers, responsible research practices offer a sanctuary for animals used in scientific studies. This research, like a beacon of hope, reminds us that compassion and innovation can coexist in the pursuit of scientific progress.
Dr. Camel's Conclusion
This study, like an oasis in the vast and often unforgiving landscape of animal research, offers a new path forward for drug safety testing. The researchers have demonstrated the feasibility of combining repeated dose toxicity studies with TK analysis using a plasma micro sampling method, a novel approach that reduces the number of blood samples required from each animal. This research is a reminder that progress and compassion can go hand in hand, leading to better outcomes for both human and animal subjects.
Date :
- Date Completed 2018-11-26
- Date Revised 2019-12-10
Further Info :
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