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 that it applies to comparative effect size studies using in vitro experimental techniques. 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 46 inclusion in a systematic review or chemical assessment.
WHALEY Paul;
VIST Gunn E.;
AMES Heather M.;
BEARTH Angela;
DI CONSIGLIO Emma;
HUSØY Trine;
SPYROPOULOU Anastasia;
CAMILLA SVENDSEN Camilla Svendsen;
TCHEREMENSKAIA Olga;
DAVENPORT Miles;
HARTUNG Thomas;
HOFFMANN Sebastian;
HOOIJMANS Carlijn R.;
MCCANN Sarah;
PRIETO-PERAITA Pilar;
ROONEY Andrew A.;
SPILIOTI Eliana;
MATHISEN Gro H.;
2026-09-09
ACADEMIC PRESS INC ELSEVIER SCIENCE
JRC146141
1096-0295 (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC146141,
10.1016/j.yrtph.2026.106185 (online),
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