Evidence map›Paper›PMID 39403541›Full record

ArticleHeliyon2024

Quality by design-based approach for the development of an analytical method for quantifying ponatinib in rat plasma.

Nahyun Koo, Eun Ji Lee, Min Ju Kim, Minjung Park, Kyeong-Ryoon Lee, Yoon-Jee Chae

Abstract read
In one paragraph

Article in Heliyon, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Nahyun KooCollege of Pharmacy, Woosuk University, Wanju, 55338, Republic of Korea.
Eun Ji LeeCollege of Pharmacy, Woosuk University, Wanju, 55338, Republic of Korea.
Min Ju KimLaboratory Animal Resource Center, Korea Research Institute of Bioscience and Biotechnology, Cheongju, 28116, Republic of Korea.
Minjung ParkLaboratory Animal Resource Center, Korea Research Institute of Bioscience and Biotechnology, Cheongju, 28116, Republic of Korea.
Kyeong-Ryoon LeeLaboratory Animal Resource Center, Korea Research Institute of Bioscience and Biotechnology, Cheongju, 28116, Republic of Korea.
Yoon-Jee ChaeCollege of Pharmacy, Woosuk University, Wanju, 55338, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ponatinib is a potent tyrosine kinase inhibitor that is approved for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. To further expand its clinical applications, accurate quantification of ponatinib in plasma is essential. In this study, we developed and validated a sensitive and selective high-performance liquid chromatography (HPLC) method coupled with a fluorescence detector (FLD) to measure ponatinib concentrations in rat plasma using the Analytical Quality by Design approach. Briefly, we screened and optimized the critical method parameters using the Taguchi and Box-Behnken designs. The developed method had excellent linearity in the range of 1-1000 ng/mL, sensitivity, and reproducibility, and required minimal sample volume and a short run time. Compared with previously reported HPLC-ultraviolet (UV) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods, this HPLC-FLD method offers superior sensitivity, simpler sample preparation, and greater efficiency. We successfully used this method in a pharmacokinetic study in rats to obtain reliable data on ponatinib plasma concentrations. Altogether, this analytical method will be applicable in several analytical conditions and will support further pharmacokinetic and clinical investigations of ponatinib for various cancer treatments.

Indexed as

Analytical quality by designBox-Behnken designMethod development and validationPonatinibTaguchi method

Identifiers

PMID39403541
PMCPMC11471595

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.