Eq-DIAGNOBATCH, a Shiny application for topical product equivalence with batch effect and multivariate outlier analysis

Abstract

The Eq-DIAGNOBATCH application presented here complements a previous theoretical article about establishing the equivalence of topical products in a parallel linear model, accounting for a batch effect or not. This application provides a very simple way of carrying out the equivalence test for this type of situation, efficiently obtaining the estimates of the parameters of interest (equivalence intervals, geometric mean ratio, and variance components), and allowing calculations to be performed assuming a batch effect or not. It also examines the statistical implications of the presence of outliers in the sample, from both a univariate and multivariate point of view. The operation and mode of use of Eq-DIAGNOBATCH are presented, including examples related with the quality and equivalence of topical products and bioequivalence analysis. Some of these examples come from the literature and others from real-life industry case studies.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The application is free to use and can be accessed at the following link: https://amonleongbiost3.shinyapps.io/EqDIAGNOBATCH/. The different usage dataframes can be found in https://github.com/amonleong/EqDIAGNOBATCH.

https://github.com/amonleong/EqDIAGNOBATCH

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