Considerations for Applying Route-to-Route Extrapolation to Assess the Safety of Oral Exposure to Substances.

Shruti V Kabadi, Jeffrey Fisher, Benjamin Hung, Jason Aungst

Abstract read

In one paragraph

Article in Biomolecules, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Shruti V KabadiU.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, 5001 Campus Drive, HFS-275, College Park, MD 20740, USA.

Jeffrey FisherU.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, USA.

Benjamin HungU.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, 5001 Campus Drive, HFS-275, College Park, MD 20740, USA.

Jason AungstU.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, 5001 Campus Drive, HFS-275, College Park, MD 20740, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety evaluation of oral exposure to substances, such as food ingredients, additives, and their constituents, relies primarily on a careful evaluation and analysis of data from oral toxicity studies. When relevant oral toxicity studies are unavailable or may have significant data gaps that make them inadequate for use in safety evaluations, data from non-oral toxicity studies in animals, such as studies on inhalation, dermal exposure, etc., might be used in support of or in place of oral toxicity studies through route-to-route (R-t-R) extrapolation. R-t-R extrapolation is applied on a case-by-case basis as it requires attention to and comparison of substance-specific toxicokinetic (TK) and toxicodynamic (TD) data for oral and non-oral exposure routes. This article provides a commentary on the utility of R-t-R extrapolation to assess the safety of oral exposure to substances, with an emphasis on the relevance of TK and systemic toxicity data.

Indexed as

Administration, InhalationSafetyAnimalsequivalent oral daily doseinhalation dataroute-to-routetoxicokineticsvolatile compoundswash in–wash out

Identifiers

PMID36671390

DOI10.3390/biom13010005

PMCPMC9855723

What OpenQuestion holds

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LicenceCC BY

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.