Technical Framework for High Quality New Approach Methodologies (NAMs)
Elijah Petersen, John T. Elliott, John Gordon, Nicole Kleinstreuer, Emily Reinke, Matthias Roesslein, Blaza Toman
New approach methodologies (NAMs) are in vitro, in chemico, and computational approaches that can potentially be used to reduce animal testing. For NAMs that require laboratory experiments, it is critical that they provide consistent and reliable results. While guidance has been provided on improving the reproducibility of NAMs, there is not yet an overarching technical framework that details how to add measurement quality features into a protocol. In this manuscript, we discuss such a framework and provide a step-by step process describing how to refine a protocol using basic quality tools: cause-and-effect analysis, flowcharts, check sheets, control charts, histograms, and scatterplots. The steps in this framework include 1) conceptual evaluation of the assay, 2) within laboratory evaluation, 3) statistical data analysis and reporting, and 4) interlaboratory testing (if needed). While each of these steps has discrete components, they are all inter-related and insights from any step can influence the others. Following the steps in this framework can help reveal the advantages and limitations of different design choices. Overall, the use of this technical framework can support the development of robust NAMs that can meet research and regulatory needs.
, Elliott, J.
, Gordon, J.
, Kleinstreuer, N.
, Reinke, E.
, Roesslein, M.
and Toman, B.
Technical Framework for High Quality New Approach Methodologies (NAMs), Environmental Health Perspectives, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=934270
(Accessed December 4, 2023)