Quality INSIGHTS

With growing alarm at the failure to replicate published, influential studies, the life sciences community is turning their attention to the causes and consequences of the replication crisis. How can we improve in vivo research to secure the reliability of our results? Reproducibility in Life Sciences While some of the most public replication failures came out of the "softer" sciences, such as psychology or economics, the biological...

Proposed changes to the ICH S1 guidelines for rodent carcinogenicity testing of human pharmaceuticals would allow sponsors to waive the requirement for a two-year rat bioassay under certain conditions. A final ruling and guidance update are expected in June of 2018. Re-Examining Carcinogenicity Testing In 2011, Sistare et al. conducted a retrospective analysis of the data on two-year rat carcinogenicity and chronic toxicity studies in rats with...

Timed pregnant mice and rats are important research tools, with applications in developmental research, genetic engineering, and generating tissue cultures. They are the most efficient way to obtain a cohort of embryos, fetuses, or pups with a precisely defined, matched age. But what exactly are timed pregnant mice? What Are Timed Pregnant Mice and Rats? A timed pregnant female is a mouse or rat with a precisely...

The annual Society of Toxicology (SOT) meeting is the largest toxicological meeting in the world. The 57th Annual Meeting and ToxExpo was held in San Antonio, Texas, and drew more than 6,100 scientists from Europe, Africa, Asia, Canada, and almost every state of the United States. This is where scientists go to discover all the advances in toxicology from the past year and to meet with colleagues,...

A frankly shocking amount of research funding — perhaps as high as 85%, or $200 billion — is wasted on poorly designed studies. How can you improve your study design to avoid falling into this trend? Each day scientists plan, conduct, analyze and debate study design, hoping their efforts will lead to a cure or a new understanding of a critical biological pathway. Is it easy? No...

What is genetic quality and how does it impact in vivo research? Dr. Ana Perez addressed this topic in a recent webinar, making the case that research reproducibility requires high genetic quality of laboratory rodents. Genetic Background Categories In terms of their genetic background, Dr. Perez divided animal models into four basic categories. Each category requires a distinct approach to maintaining genetic integrity: Inbred strains have a...

Proper sample size calculation is both a scientific and ethical imperative. Researchers are routinely asked to justify the number of animals used in their studies, either by regulatory bodies, funding agencies or, increasingly, by journal editors. In accordance with the 3R's, studies should be designed to reduce the number of animals used to meet scientific objectives. While the ethical reasons underlying such reductions are obvious, it is...

Quality and reproducibility are the focus of much scientific literature, reviews, and commentaries. Knowledge cannot advance without confidence in the reproducibility of our research. If you work in a laboratory animal facility or use animal models in your research, you know proper training is imperative to quality, reproducibility, and success. Yet, there is no single source of information, regulations, or training materials we can turn to. The...

Reproducibility Requires Genetic Quality The genetic integrity of laboratory mice and rats is an important contributor to research reproducibility, which is why commercial animal vendors invest in maintaining the genetic quality of standard inbred and outbred strains. As the technology to produce genetically engineered models (GEMs) becomes more widespread, a growing majority of GEMs are bred and used at individual institutions. This decentralization has created concerns regarding...

In the spirit of Russell and Burch's 3Rs, scientists are developing new tools and methodologies to reduce the use of animal models wherever possible. A very good example is the rasH2 mouse model, which was developed as an alternative to the traditional, two-year carcinogenicity testing of compounds for mutagenic and non-mutagenic chemically- induced tumor formation. Transgenic Mice as an Ethical Alternative The rasH2 mouse was developed in...