Evidence map›Paper›PMID 34215864›Full record

ReviewNature protocols2021

Thrombin generation test based on a 96-channel pipettor for evaluation of FXIa procoagulant activity in pharmaceuticals.

Leonid A Parunov, Maria E Shea, Yideng Liang, Stepan S Surov, Maitreyi Chattopadhyay, Timothy K Lee, Dorothy E Scott, Mikhail V Ovanesov

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
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

5 citing papers in PubMed, 8 citations in OpenAlex.

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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 at 1 institution in 1 country.

Leonid A Parunov *Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0002-8892-8908
Maria E Shea *Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0002-1153-1996
Yideng Liang *Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Stepan S SurovCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Maitreyi ChattopadhyayCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Timothy K LeeCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Dorothy E ScottCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Mikhail V OvanesovCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. mikhail.ovanesov@fda.hhs.gov.ORCID http://orcid.org/0000-0003-2509-1781
Center for Biologics Evaluation and Research · US

Funding

FDA HHS
6 · The paper itself

Abstract

Thrombin generation (TG) assays are used widely to investigate both diseases and drugs that impact thrombosis and bleeding. TG assays were also instrumental in the identification of thrombogenic impurities in immune globulin products, which were associated with thrombotic adverse events in patients. TG assays are therefore now used by quality control laboratories of plasma derivative drug manufacturers and regulatory agencies responsible for the safety testing and release of immune globulin products. In this protocol, we describe a robust and sensitive version of the TG assay for quantitative measurement of thrombogenic activity in immune globulin products. Compared with the version of the assay commonly used in clinical laboratories that compares individual patient plasma samples with normal donor samples, our TG assay is suitable for quick (170-260 min) semiautomated analysis of multiple drug samples against the World Health Organization international standard for factor XIa. Commercially available reagents can be used for the assay, and it does not require specialized equipment. The protocol can be easily adapted for the measurement of the procoagulant activity of other biopharmaceuticals, e.g., coagulation factors.

Indexed as

AnticoagulantsDrug Evaluation, PreclinicalFactor XIaHumansThrombinAnticoagulantsFactor XIaThrombin

Identifiers

PMID34215864
OpenAlexW3173479407

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.