Evidence map›Paper›PMID 36178248›Full record

ArticleClinical and translational science2023

Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study.

Jiaying Wang, Jinliang Chen, Lu Wang, Dandan Yang, Rong Shao, Honggang Lou, Zourong Ruan, Bo Jiang

Abstract read
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Article in Clinical and translational science, 2023. 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.

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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

8 authors.

Jiaying WangCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.ORCID 0000-0003-0183-9484
Jinliang ChenCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Lu WangCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Dandan YangCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Rong ShaoCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Honggang LouCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Zourong RuanCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Bo JiangCenter of Clinical Pharmacology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.ORCID 0000-0003-2406-0959

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In vitro-in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and facilitate certain regulatory decisions. Here, we developed an IVIVC model for pitavastatin calcium, a basic Biopharmaceutics Classification System (BCS) II lipid-lowering drug, which was then used to predict the BE outcome of formulations manufactured at two manufacturers. In addition, virtual trials using the IVIVC model using pH 4.0 acetate buffer dissolution showed similarity in areas under the curves and maximum plasma concentration (C

Indexed as

QuinolinesDrug CompoundingHumansModels, BiologicalSolubilityTherapeutic EquivalencypitavastatinQuinolines

Identifiers

PMID36178248
PMCPMC9841298

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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.