Evidence map›Paper›PMID 33104941›Full record

ArticleThe AAPS journal2020

Simulation Informed Design and Performance of In Vitro Bioequivalence Trials for Particle Size Distributions.

William J Ganley, Jagdeep Shur, Robert Price

Abstract read
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In one paragraph

Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

William J GanleyNanopharm Ltd, an Aptar Pharma Company, Cavendish House, Hazell Drive, Newport, NP10 8FY, UK. w.ganley@nanopharm.co.uk.ORCID 0000-0001-8885-2475
Jagdeep ShurNanopharm Ltd, an Aptar Pharma Company, Cavendish House, Hazell Drive, Newport, NP10 8FY, UK.
Robert PriceNanopharm Ltd, an Aptar Pharma Company, Cavendish House, Hazell Drive, Newport, NP10 8FY, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study used statistical simulations to investigate the performance of the population bioequivalence test applied to image-based particle size measurements (such as morphologically directed Raman spectroscopy) and methods for designing in vitro bioequivalence trials using prior information. Simulations of in vitro population bioequivalence trials were conducted across a range of representative D

Indexed as

Equivalence Trials as TopicResearch DesignTherapeutic EquivalencyComputer SimulationHumansModels, BiologicalParticle Sizeorally inhaled and nasal drug productsparticle size distributionpopulation bioequivalencesimulation

Identifiers

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.