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

Paper Details 
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 IconDr.Camel's Paper Summary Blogラクダ博士について

ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。

* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。


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 :
  1. Date Completed 2018-11-26
  2. Date Revised 2019-12-10
Further Info :

Pubmed ID

30405001

DOI: Digital Object Identifier

10.2131/jts.43.685

Related Literature

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

This site uses cookies. Visit our privacy policy page or click the link in any footer for more information and to change your preferences.