Regulatory toxicology and pharmacology : RTP · 2026
External validity for in vitro toxicity studies: an important but challenging concept.
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Whaley Paul, Vist Gunn E, Ames Heather M, Bearth Angela, Di Consiglio Emma, Husøy Trine, Spyropoulou Anastasia, Svendsen Camilla, Tcheremenskaia Olga, Davenport Miles P, Hartung Thomas, Hoffmann Sebastian, Hooijmans Carlijn R, McCann Sarah, Prieto Pilar, Rooney Andrew A, Spilioti Eliana, Mathisen Gro H
Аннотация
In this paper, we present an operational conceptualisation of external validity for in vitro studies, to support the development of the forthcoming INVITES-EX tool. We define external validity as consisting of a concept of applicability and a concept of generalisability, and explain how it applies to in vitro comparative effect size studies. We argue that external validity assessment is relevant at two stages of evidence synthesis, during study screening and during evidence integration. Because evidence integration is complex and likely best supported by guidance, we conclude that INVITES-EX should be targeted at assessing the applicability of individual studies and used when screening studies for inclusion in a systematic review or chemical assessment.