Evidence map›Paper›PMID 38680345›Full record

ArticleACS omega2024

Establishment and Validation of an Automated System for the Antifactor IIa Assay: A Case Study of Potency Assessment of a Pharmaceutical Gel Formulation.

Gokselin Ozgen, Merve Turk Gezer, Guliz Armagan, Petek Ballar Kirmizibayrak, Ayfer Yalcin, Ozgen Ozer, Banu Ozkirim Arslan, Gonul Kayar, Udaya Kumar Dude, Aysegul Kaymak Ozdemir

Abstract read
In one paragraph

Article in ACS omega, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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.

Gokselin OzgenAbdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye.
Merve Turk GezerAbdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye.
Guliz ArmaganFaculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye.ORCID https://orcid.org/0000-0001-6466-2263
Petek Ballar KirmizibayrakFaculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye.
Ayfer YalcinFaculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye.
Ozgen OzerFaculty of Pharmacy, Department of Pharmaceutical Technology, Ege University, Bornova, Izmir 35040, Türkiye.
Banu Ozkirim ArslanAbdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye.
Gonul KayarAbdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye.
Udaya Kumar DudeAbdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye.
Aysegul Kaymak OzdemirFaculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye.ORCID https://orcid.org/0000-0001-5153-9602

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antithrombotic agents and anticoagulant drugs, such as those from the heparin family, are employed in clinical settings for the prevention and treatment of clotting, thromboembolism, and wound healing. The potency assessment of antithrombotic agents is typically conducted using antifactor IIa assay with manual systems which are time-consuming and often lack repeatability. Here, we present a novel automated system that significantly enhances assay repeatability, attaining an outstandingly low relative standard deviation (RSD) % of only 0.6% for repeatability. This system has been applied to a pharmaceutical gel formulation for wound healing developed by Abdi Ibrahim Pharmaceuticals R&D Center as a case study for validation. The automated system demonstrated substantial improvements over manual systems in linearity (

Identifiers

PMID38680345
PMCPMC11044257

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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.