Evidence map›Paper›PMID 24670388›Full record

ArticleCPT: pharmacometrics & systems pharmacology2014

Physiologically based pharmacokinetic modeling framework for quantitative prediction of an herb-drug interaction.

S J Brantley, B T Gufford, R Dua, D J Fediuk, T N Graf, Y V Scarlett, K S Frederick, M B Fisher, N H Oberlies, M F Paine

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% of its field
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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Review
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  8. Article
  9. Article
  10. The Chemistry of Kratom [Journal of natural products · 2020
    Article
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  13. Review
  14. Article
  15. Article
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  18. Article
  19. Chemoenzymatic Synthesis, Characterization, and Scale-Up of Milk Thistle Flavonolignan Glucuronides.Drug metabolism and disposition: the biological fate of chemicals · 2015
    Article
  20. 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

10 authors at 5 institutions in 1 country.

S J BrantleyEshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
B T GuffordCollege of Pharmacy, Washington State University, Spokane, Washington, USA.
R DuaEshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
D J FediukEshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
T N GrafDepartment of Chemistry and Biochemistry, The University of North Carolina at Greensboro, Greensboro, North Carolina, USA.
Y V ScarlettSchool of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
K S FrederickBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
M B FisherProPharma Services, LLC, Oxford, Connecticut, USA.
N H OberliesDepartment of Chemistry and Biochemistry, The University of North Carolina at Greensboro, Greensboro, North Carolina, USA.
M F PaineCollege of Pharmacy, Washington State University, Spokane, Washington, USA.
University of North Carolina at Chapel Hill · USUniversity of North Carolina at Greensboro · USWashington State University Spokane · USBoehringer Ingelheim (United States) · USCheminPharma (United States) · US

Funding

UNC Clinical and Translational Science AwardUL1TR000083 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2012 to 2013
$11.6M
Mechanisms Underlying Drug-Diet InteractionsR01GM077482 · NIGMS · WASHINGTON STATE UNIVERSITY · PI PAINE, MARY F · 2007 to 2014
$3.3M
NCATS NIH HHS UL1 TR000083NIGMS NIH HHS R01 GM077482
6 · The paper itself

Abstract

Herb-drug interaction predictions remain challenging. Physiologically based pharmacokinetic (PBPK) modeling was used to improve prediction accuracy of potential herb-drug interactions using the semipurified milk thistle preparation, silibinin, as an exemplar herbal product. Interactions between silibinin constituents and the probe substrates warfarin (CYP2C9) and midazolam (CYP3A) were simulated. A low silibinin dose (160 mg/day × 14 days) was predicted to increase midazolam area under the curve (AUC) by 1%, which was corroborated with external data; a higher dose (1,650 mg/day × 7 days) was predicted to increase midazolam and (S)-warfarin AUC by 5% and 4%, respectively. A proof-of-concept clinical study confirmed minimal interaction between high-dose silibinin and both midazolam and (S)-warfarin (9 and 13% increase in AUC, respectively). Unexpectedly, (R)-warfarin AUC decreased (by 15%), but this is unlikely to be clinically important. Application of this PBPK modeling framework to other herb-drug interactions could facilitate development of guidelines for quantitative prediction of clinically relevant interactions.CPT Pharmacometrics Syst. Pharmacol. (2014) 3, e107; doi:10.1038/psp.2013.69; advance online publication 26 March 2014.

Identifiers

PMID24670388
PMCPMC4042458
OpenAlexW2037705821

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.