ArticleFrontiers in pharmacology2026
All things are active … new approach methods for excipient safety.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
Excipients make up the majority of most medicines by mass, yet they are still called "inactive," still largely qualified against a 2005 guidance, and still assessed product by product with animal studies that answer the wrong questions. The past decade has dismantled the "inactive" assumption: polyethylene glycol and polysorbate anaphylaxis, benzyl alcohol gasping syndrome, propylene glycol acidosis, benzalkonium bronchospasm, and the recurrent diethylene glycol mass poisonings of children all show that excipient risk is real, but that it is contextual rather than intrinsic. I argue that this contextual character makes excipients an almost ideal proving ground for New Approach Methodologies (NAMs). Excipient hazard depends on route, dose, duration, formulation, impurities, and patient population-exactly the variables that exposure science, computational toxicology, and human
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