Evidence map›Paper›PMID 29882956›Full record

ReviewClinical pharmacology and therapeutics2018

A Tiered Approach for the Evaluation of the Safety of Botanicals Used as Dietary Supplements: An Industry Strategy.

Amy L Roe, Donna A McMillan, Catherine Mahony

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2018. 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. Review
  2. Hepatotoxicity of usnic acid and underlying mechanisms.Journal of environmental science and health. Part C, Toxicology and carcinogenesis · 2025
    Review
  3. Article
  4. Biomolecules · 2024
    Review
  5. Article
  6. Review
  7. Review
  8. Hepatotoxicity due to herbal dietary supplements: Past, present and the future.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2022
    Review
  9. Article
  10. Review
  11. Review
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.

Amy L RoeThe Procter and Gamble Company, Mason Business Center, Cincinnati, Ohio, USA.
Donna A McMillanThe Procter and Gamble Company, Mason Business Center, Cincinnati, Ohio, USA.
Catherine MahonyProcter and Gamble Technical Centres Ltd, Greater London Innovation Centre, Egham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Exposure to botanicals in dietary supplements is increasing across many geographies; with increased expectations from consumers, regulators, and industry stewards centered on quality and safety of these products. We present a tiered approach to assess the safety of botanicals, and an in silico decision tree to address toxicity data gaps. Tier 1 describes a Threshold of Toxicologic Concern (TTC) approach that can be used to assess the safety of conceptual levels of botanicals. Tier 2 is an approach to document a history of safe human use for botanical exposures higher than the TTC. An assessment of botanical-drug interaction (BDI) may also be necessary at this stage. Tier 3 involves botanical chemical constituent identification and safety assessment and the in silico approach as needed. Our novel approaches to identify potential hazards and establish safe human use levels for botanicals is cost and time efficient and minimizes reliance on animal testing.

Indexed as

Consumer Product SafetyDrug IndustryPatient SafetyAnimalsDietary SupplementsHumansPhytotherapyPlant PreparationsPlants, MedicinalQuality ControlRisk AssessmentToxicity TestsPlant Preparations

Identifiers

PMID29882956
PMCPMC6175063

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.