Evidence map›Paper›PMID 29983598›Full record

ArticleMedical devices (Auckland, N.Z.)2018

Development of an advanced injection time model for an autoinjector.

Thomas Thueer, Lena Birkhaeuer, Declan Reilly

Abstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  4. Article
  5. 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

3 authors.

Thomas ThueerDevice Development, Pharma Technical Development Europe, F. Hoffmann-La Roche Ltd, Basel, Switzerland, thomas.thueer@roche.com.
Lena BirkhaeuerDevice Development, Pharma Technical Development Europe, F. Hoffmann-La Roche Ltd, Basel, Switzerland, thomas.thueer@roche.com.
Declan ReillyDevice Development, Pharma Technical Development Europe, F. Hoffmann-La Roche Ltd, Basel, Switzerland, thomas.thueer@roche.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis work describes an advanced physics-based mathematical model that accurately predicts autoinjector injection time. Autoinjectors are a well-established technology for parenteral drug delivery and quantifying the probability to achieve a given injection time is critical to the successful development and commercial launch of the autoinjector.

methodEach parameter that can influence injection time was treated as a statistical variable with an appropriate distribution function. Monte Carlo simulation was used to obtain the probability of achieving the required injection time. Sensitivity analyses were performed to identify those parameters most critical in contributing to the overall injection time. To validate the model, a number of experiments were conducted on autoinjectors, with key contributors to injection time measured and characterized.

resultsThe results showed excellent agreement between modeled and measured injection time. The modeling error for all investigated device configurations was smaller than 12% and the error range was less than 6%. The consistent over-estimation of injection time suggests a small bias in the model which could be accounted for by reducing internal friction.

conclusionThis work provides evidence that the selected modeling approach, which aims for a simple yet computationally inexpensive model, is accurate and enables running comprehensive statistical simulations to determine the full range of expected injection times due to component variability.

Indexed as

model validationplunger forcesensitivity analysisstopper frictionviscosity

Identifiers

PMID29983598
PMCPMC6027704

What OpenQuestion holds

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LicenceCC BY-NC
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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.