Evidence map›Paper›PMID 39102093›Full record

ArticleClinical pharmacokinetics2024

Clinical Trial Data-Driven Risk Assessment of Drug-Drug Interactions: A Rapid and Accurate Decision-Making Tool.

Tong Yuan, Fulin Bi, Kuan Hu, Yuqi Zhu, Yan Lin, Jin Yang

Abstract readValidation Study
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Tong YuanKey Laboratory of Drug Metabolism and Pharmacokinetics, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang Rd, Nanjing, 210009, People's Republic of China.
Fulin BiKey Laboratory of Drug Metabolism and Pharmacokinetics, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang Rd, Nanjing, 210009, People's Republic of China.
Kuan HuKey Laboratory of Drug Metabolism and Pharmacokinetics, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang Rd, Nanjing, 210009, People's Republic of China.
Yuqi ZhuJiangsu Key Laboratory of Carcinogenesis and Intervention, School of Basic Medical Sciences and Clinical Pharmacy, China Pharmaceutical University, Nanjing, People's Republic of China.
Yan LinDepartment of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, 639 Longmiandadao Rd, Nanjing, 211198, People's Republic of China. 1020202619@cpu.edu.cn.
Jin YangKey Laboratory of Drug Metabolism and Pharmacokinetics, School of Pharmacy, China Pharmaceutical University, 24 Tongjiaxiang Rd, Nanjing, 210009, People's Republic of China. cpu_yj@163.com.ORCID 0009-0008-0742-2675

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn clinical practice, the vast array of potential drug combinations necessitates swift and accurate assessments of pharmacokinetic drug-drug interactions (DDIs), along with recommendations for adjustments. Current methodologies for clinical DDI evaluations primarily rely on basic extrapolations from clinical trial data. However, these methods are limited in accuracy owing to their lack of a comprehensive consideration of various critical factors, including the inhibitory potency, dosage, and type of the inhibitor, as well as the metabolic fraction and intestinal availability of the substrate.

objectiveThis study aims to propose an efficient and accurate clinical pharmacokinetic-mediated DDI assessment tool, which comprehensively considers the effects of inhibitory potency and dosage of inhibitors, intestinal availability and fraction metabolized of substrates on DDI outcomes.

methodsThis study focuses on DDIs caused by cytochrome P450 3A4 enzyme inhibition, utilizing extensive clinical trial data to establish a methodology to calculate the metabolic fraction and intestinal availability for substrates, as well as the concentration and inhibitory potency for inhibitors (

resultsFirst, the reliability of the in vivo

conclusionsThis study offers a rapid and accurate approach for assessing the risk of pharmacokinetic-mediated DDIs in clinical practice, providing a foundation for rational combination drug use and dosage adjustments.

Indexed as

Area Under CurveClinical Trials as TopicDecision Support TechniquesDrug InteractionsIntestinesCytochrome P-450 CYP3AHumansPharmacokineticsCYP3A4 protein, humanCytochrome P-450 CYP3A

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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.