Evidence map›Paper›PMID 29752982›Full record

ArticleFood and chemical toxicology : an international journal published for the British Industrial Biological Research Association2018

How similar is similar enough? A sufficient similarity case study with Ginkgo biloba extract.

Natasha R Catlin, Bradley J Collins, Scott S Auerbach, Stephen S Ferguson, James M Harnly, Chris Gennings, Suramya Waidyanatha, Glenn E Rice, Stephanie L Smith-Roe, Kristine L Witt and 1 more

Abstract read
In one paragraph

Article in Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

24 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Working with the natural complexity: Selection and characterization of black cohosh root extract for use in toxicology testing.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2022
    Article
  7. Article
  8. Relationships between constituents of energy drinks and beating parameters in human induced pluripotent stem cell (iPSC)-Derived cardiomyocytes.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2021
    Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. A strategy for test article selection and phytochemical characterization of Echinacea purpurea extract for safety testing.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2020
    Article
  15. Improving natural product research translation: From source to clinical trial.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2020
    Article
  16. Evaluating Sufficient Similarity of Botanical Dietary Supplements: Combining Chemical and In Vitro Biological Data.Toxicological sciences : an official journal of the Society of Toxicology · 2019
    Article
  17. Review
  18. Article
  19. Article
  20. Finding the bad actor: Challenges in identifying toxic constituents in botanical dietary supplements.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2019
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Natasha R CatlinDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Bradley J CollinsDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Scott S AuerbachDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Stephen S FergusonDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
James M HarnlyU.S. Department of Agriculture, Beltsville, MD, USA.
Chris GenningsIcahn School of Medicine, Mount Sinai Hospital, New York, NY, USA.
Suramya WaidyanathaDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Glenn E RiceU.S. Environmental Protection Agency, Cincinnati, OH, USA.
Stephanie L Smith-RoeDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Kristine L WittDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Cynthia V RiderDivision of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA. Electronic address: cynthia.rider@nih.gov.

Funding

Toxicological Assessments for the National Toxicology ProgramZIAES103316 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI WALKER, NIGEL J · 2016 to 2019
$31.9M
Biomolecular Screening and Alternative Approaches for the National Toxicology ProgramZIAES103318 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI CASEY, WARREN · 2016 to 2021
$25.0M
Intramural NIH HHS Z99 ES999999
6 · The paper itself

Abstract

Botanical dietary supplements are complex mixtures that can be highly variable in composition and quality, making safety evaluation difficult. A key challenge is determining how diverse products in the marketplace relate to chemically and toxicologically characterized reference samples (i.e., how similar must a product be in order to be well-represented by the tested reference sample?). Ginkgo biloba extract (GBE) was used as a case study to develop and evaluate approaches for determining sufficient similarity. Multiple GBE extracts were evaluated for chemical and biological-response similarity. Chemical similarity was assessed using untargeted and targeted chemistry approaches. Biological similarity was evaluated using in vitro liver models and short-term rodent studies. Statistical and data visualization methods were then used to make decisions about the similarity of products to the reference sample. A majority of the 26 GBE samples tested (62%) were consistently determined to be sufficiently similar to the reference sample, while 27% were different from the reference GBE, and 12% were either similar or different depending on the method used. This case study demonstrated that approaches to evaluate sufficient similarity allow for critical evaluation of complex mixtures so that safety data from the tested reference can be applied to untested materials.

Indexed as

AnimalsBiological AssayGene Expression RegulationGinkgo bilobaGinkgo ExtractHepatocytesHumansPhytotherapyPlant ExtractsRatsTherapeutic EquivalencyGinkgo biloba extractGinkgo ExtractPlant Extracts

Identifiers

PMID29752982
PMCPMC6979324

What OpenQuestion holds

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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.