Evidence map›Paper›PMID 35188636›Full record

ArticleMethods in molecular biology (Clifton, N.J.)2022

In Silico Models for Repeated-Dose Toxicity (RDT): Prediction of the No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL) for Drugs.

Fabiola Pizzo, Domenico Gadaleta, Emilio Benfenati

Abstract read
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In one paragraph

Article in Methods in molecular biology (Clifton, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

3 authors.

Fabiola PizzoFEED Unit, European Food Safety Authority, Parma, Italy. Fabiola.PIZZO@efsa.europa.eu.
Domenico GadaletaIstituto di Ricerche Farmacologiche "Mario Negri" IRCCS, Milan, Italy.
Emilio BenfenatiIstituto di Ricerche Farmacologiche "Mario Negri" IRCCS, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many regulatory contexts require the evaluation of repeated-dose toxicity (RDT) studies conducted in laboratory animals. The main outcome of RDT studies is the identification of the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) that are normally used as point of departure for the establishment of health-based guidance values. Since in vivo RDT studies are expensive and time-consuming, in silico approaches could offer a valuable alternative. However, NOAEL and LOAEL modeling suffer some limitations since they do not refer to a single end point but to several different effects, and the doses used in experimental studies strongly influence the results. Few attempts to model NOAEL and LOAEL have been reported. The available database and models for the prediction of NOAEL and LOAEL are reviewed here.

Indexed as

Pharmaceutical PreparationsAnimalsComputer SimulationNo-Observed-Adverse-Effect LevelRisk AssessmentPharmaceutical PreparationsChronic toxicityDrug safetyIn silico modelsLOAELNOAELRepeated-dose toxicity

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.