Evidence map›Paper›PMID 42212686›Full record

ArticleDrug delivery2026

Human factors validation study of a disposable autoinjector (Bmab 1200 autoinjector) for subcutaneous delivery of Ustekinumab.

Sam Moses K, Rohini Kamaraj, Suryaprakash Konda Ramachary Subramanian

Abstract readValidation Study
In one paragraph

Article in Drug delivery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

3 authors.

Sam Moses KDevices R&D, Biocon Biologics Limited, Bengaluru, Karnataka, India.ORCID 0009-0008-0981-439X
Rohini KamarajDevices R&D, Biocon Biologics Limited, Bengaluru, Karnataka, India.ORCID 0009-0001-3343-3262
Suryaprakash Konda Ramachary SubramanianDevices R&D, Biocon Biologics Limited, Bengaluru, Karnataka, India.ORCID 0009-0007-3782-9567

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ustekinumab is approved for treating moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The Bmab 1200 autoinjector is a simple, two-step device for subcutaneous ustekinumab biosimilar delivery. This was an in vitro, nonclinical, simulated-use human factors validation study to evaluate if intended users could safely and effectively use it. Ninety participants (recruited via purposive sampling) were enrolled (mean age: 43 years; range: 12-72 years), including adult and adolescent patients, lay caregivers, and healthcare professionals. Without formal training, participants performed simulated injections into foam pads. Test personnel observed, documented, debriefed, and reported any errors made by participants while completing assigned tasks and sub-tasks. Each participant was observed throughout the session and observational and performance data were collected in real time by data logger. Performance measures included injection success rates, use errors, and 24 knowledge tasks. Across these knowledge tasks, participants were required to locate, identify, and understand 28 distinct measures. Participants also provided feedback on usability and confidence levels. All participants (100%) completed unaided dose injections. A total of 20 use errors were documented: hand hygiene (

Indexed as

Biosimilar PharmaceuticalsDrug Delivery SystemsUstekinumabAdolescentAdultAgedChildDisposable EquipmentFemaleHumansInjections, SubcutaneousMaleMiddle AgedYoung AdultBiosimilar PharmaceuticalsUstekinumabAutoinjectorsimulated testinguser-centered designustekinumabvalidation study

Identifiers

PMID42212686
PMCPMC13224692

What OpenQuestion holds

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LicenceCC BY-NC
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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.