Quality INSIGHTS


Webinar Review: Genetic Integrity in Breeding Colonies

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...

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Animal Research Sample Size Calculation (and Consequences)

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...

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Resources for Improving Quality and Reproducibility in Animal Studies

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...

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Reference DNA from Key Mouse Strains Now Available

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...

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rasH2 and the 3Rs

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...

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Improving Quality with the 3Rs

Designing your animal model studies with the 3Rs in mind — Replace, Reduce, Refine — is not only more humane, but can measurably improve the quality and efficiency of your research projects. When we think of improving quality in the life sciences, we might immediately jump to poorly calibrated equipment, expired reagents, or utilizing unvalidated processes. It is obvious that these will have a negative effect on...

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Humanized Mice at the Summer Toxicology Forum

The 43rd annual Summer Toxicology forum meeting was held on July 10-12, 2017 in Annapolis Maryland. The afternoon of July 10th was dedicated to a section titled "Use of Humanized Mice for Drug Development". The session was moderated by James Monroe, PhD, senior principle scientist at Merck Research Laboratories, and included presentations by researchers at the FDA, Merck, Yale, and Taconic Biosciences followed by a panel discussion...

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Webinar Recap: Historical Control Database of Spontaneous Lesions in Tg.rasH2 Mice

On May 25, 2017, Dr. Madhav Paranjpe presented a webinar on the state of evidence surrounding the use of Tg.RasH2 carcinogenicity studies as a substitute for the two-year mouse bioassay. His presentation — "Historical Control Database of Spontaneous Lesions (Neoplastic & Non-Neoplastic) in Transgenic Tg.rasH2 Mice" — covered evidence drawn from fifty peer-reviewed studies, personal experience, and analysis of the growing body of historical control data supporting...

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Proposed Changes to ICH Carcinogenicity Testing Guidelines — Decision Delayed

While evidence mounts in support of revised carcinogenicity testing guidelines, the number of Carcinogenicity Assessment Documents (CAD) submitted to the ICH S-1 expert working group fell below expected levels. After extending the submission period by two years9, the expert working group (EWG) will meet in June of 2017 to review the conclusions of drug regulatory agencies on the viability of excluding some pharmaceutical agents from the requirement...

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Mutation Reduces Immune Response in C57BL/6J Mice

Researchers from the University of Iowa inadvertently identified an Nlrp12 missense mutation which inhibits immune responses in C57BL/6J mice. Further investigation reveals the mutation occurred prior to 1971, potentially impacting decades of research conducted on affected mouse models. Reduced Neutrophil Recruitment in C57BL/6J In this study, the authors compared C57BL/6J and C57BL/6NTac mice and noted that C57BL/6J mice had reduced neutrophil recruitment. Initially hypothesizing the difference was...

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