Evidence map›Paper›PMID 34699676›Full record

ReviewClinical and translational science2022

Adapting regulatory drug-drug interaction guidance to design clinical pharmacokinetic natural product-drug interaction studies: A NaPDI Center recommended approach.

Emily J Cox, Allan E Rettie, Jashvant D Unadkat, Kenneth E Thummel, Jeannine S McCune, Mary F Paine

Abstract readReview
In one paragraph

Review in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Translating Kratom-Drug Interactions: From Bedside to Bench and Back.Drug metabolism and disposition: the biological fate of chemicals · 2023
    Review
  5. Article
  6. 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

6 authors.

Emily J CoxDepartment of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, Washington, USA.
Allan E RettieDepartment of Medicinal Chemistry, School of Pharmacy, University of Washington, Seattle, Washington, USA.
Jashvant D UnadkatCenter of Excellence for Natural Product Drug Interaction Research, Spokane, Washington, USA.
Kenneth E ThummelCenter of Excellence for Natural Product Drug Interaction Research, Spokane, Washington, USA.
Jeannine S McCuneCenter of Excellence for Natural Product Drug Interaction Research, Spokane, Washington, USA.
Mary F PaineDepartment of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, Washington, USA.

Funding

Pharmacology CoreU54AT008909 · NCCIH · WASHINGTON STATE UNIVERSITY · PI PAINE, MARY F · 2015 to 2024
$22.4M
NCCIH NIH HHS U54 AT008909
6 · The paper itself

Abstract

Pharmacokinetic drug interactions precipitated by botanical and other natural products (NPs) remain critically understudied. Investigating these complex interactions is fraught with difficulties due to the methodologic and technical challenges associated with the inherently complex chemistries and product variability of NPs. This knowledge gap is perpetuated by a continuing absence of a harmonized framework regarding the design of clinical pharmacokinetic studies of NPs and NP-drug interactions. Accordingly, this Recommended Approach, the fourth in a series of Recommended Approaches released by the Center of Excellence for Natural Product Drug Interaction Research (NaPDI Center), provides recommendations for the design of clinical pharmacokinetic studies involving NPs. Building on prior Recommended Approaches and data generated from the NaPDI Center, such a framework is presented for the design of (1) phase 0 studies to assess the pharmacokinetics of an NP and (2) clinical pharmacokinetic NP-drug interaction studies. Suggestions for NP sourcing, dosing, study design, participant selection, sampling periods, and data analysis are presented. With the intent to begin addressing the gap between regulatory agencies' guidance documents about drug-drug interactions and contemporary NPDI research, the objective of this Recommended Approach is to propose methods for the design of clinical pharmacokinetic studies of NPs and NP-drug interactions.

Indexed as

Advisory CommitteesDrug InteractionsPharmaceutical PreparationsBiological ProductsGuidelines as TopicHumansResearch DesignBiological ProductsPharmaceutical Preparations

Identifiers

PMID34699676
PMCPMC8841492

What OpenQuestion holds

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LicenceCC BY-NC
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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.