Evidence map›Paper›PMID 27770107›Full record

ArticleToxicologic pathology2017

Is It Adverse, Nonadverse, Adaptive, or Artifact?

Arun R Pandiri, Roy L Kerlin, Peter C Mann, Nancy E Everds, Alok K Sharma, L Peyton Myers, Thomas J Steinbach

Abstract read
In one paragraph

Article in Toxicologic pathology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Integration of mechanistic and repeat dose toxicity data in the derivation of an oral reference dose for HFPO-DA.Toxicological sciences : an official journal of the Society of Toxicology · 2026
    Review
  3. A toxicological assessment ofFrontiers in toxicology · 2025
    Article
  4. Article
  5. A toxicological assessment ofFrontiers in toxicology · 2024
    Article
  6. Safety of Elixinol Hemp Extract:Journal of toxicology · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

7 authors.

Arun R Pandiri1 National Toxicology Program, Research Triangle Park, North Carolina, USA.
Roy L Kerlin2 Drug Safety Research and Development, Pfizer Inc., Groton, Connecticut, USA.
Peter C Mann3 Experimental Pathology Laboratories, Inc., Northwest, Seattle, Washington, USA.
Nancy E Everds4 Amgen Inc., South San Francisco, California, USA.
Alok K Sharma5 Covance Laboratories, Madison, Wisconsin, USA.
L Peyton Myers6 U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Thomas J Steinbach7 Experimental Pathology Laboratories, Inc., Durham, North Carolina, USA.

Funding

Intramural NIH HHS Z99 ES999999
6 · The paper itself

Abstract

One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course.

Indexed as

Adaptation, PhysiologicalArtifactsAnimalsDrug Evaluation, PreclinicalDrug-Related Side Effects and Adverse ReactionsGuidelines as TopicNo-Observed-Adverse-Effect LevelPathologyToxicity Testsadaptive responseadversityartifactnonadverse response

Identifiers

PMID27770107
PMCPMC5225139

What OpenQuestion holds

Textmetadata
LicenceTDM
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.