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Add new vignette
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vignettes/sampleSize_parallel_3A1E.Rmd

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@@ -39,6 +39,7 @@ data <- data.table::data.table(arm = c("SB2","EU_Remicade","USA_Remicade"),
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sd = c(11113.62172, 12332.41615,12113.72))
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```
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# Sample Size Calculation for AUCinf: Equivalence to EU Remicade
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This example demonstrates how to calculate the sample size required when testing the equivalence of SB2 to a reference drug, Remicade, as administered in Europe. The goal is to determine the minimum number of participants needed to ensure adequate power for the equivalence test.
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---
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title: "Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 2 Endpoints"
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author: "Thomas Debray"
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date: "`r format(Sys.time(), '%B %d, %Y')`"
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output:
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html_document:
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fig_caption: yes
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fig_width: 9
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fig_height: 6
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vignette: >
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%\VignetteIndexEntry{Bioequivalence Tests for Parallel Trial Designs: 3 Arms, 2 Endpoints}
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%\VignetteEngine{knitr::rmarkdown}
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%\VignetteEncoding{UTF-8}
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bibliography: 'references.bib'
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link-citations: yes
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---
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```{r setup, include=FALSE, message = FALSE, warning = FALSE}
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knitr::opts_chunk$set(echo = TRUE)
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knitr::opts_chunk$set(comment = "#>", collapse = TRUE)
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options(rmarkdown.html_vignette.check_title = FALSE) #title of doc does not match vignette title
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doc.cache <- T #for cran; change to F
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```
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# Introduction
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In many studies, it is necessary to evaluate equivalence across multiple primary variables. For instance, the European Medicines Agency (EMA) recommends demonstrating equivalence for both **Area Under the Curve** (AUC) and **maximum concentration** (Cmax) when assessing pharmacokinetic properties.
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When multiple primary endpoints are involved, a decision must be made on the desired criteria for equivalence:
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* Equivalence for All Primary Endpoints
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* This is the most common setting and is often referred to as having *multiple co-primary endpoints*.
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* Equivalence must be demonstrated for **all** endpoints to conclude overall equivalence.
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* Equivalence for At Least One Primary Endpoint
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* Known as having *multiple primary endpoints*.
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* Equivalence is required for **at least one** endpoint to meet the study's objectives.
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This vignette presents advanced techniques for calculating sample size in parallel trial designs involving three treatment arms and two endpoints. Specifically, it focuses on bioequivalence testing between a new treatment (SB2) and a reference drug (Remicade) administered in two distinct locations (EU_Remicade and USA_Remicade).
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# Methodology and Assumptions
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The endpoints of interest are:
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* AUCinf: Area Under the Curve (infinity)
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* Cmax: Maximum concentration
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For both endpoints, the analysis assumes that:
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* Summary data are available on the original scale (e.g., mean and standard deviation).
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* These data are provided for each treatment arm.
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This vignette demonstrates how to compute the required sample size for testing bioequivalence, ensuring robust conclusions across endpoints in this three-arm parallel trial design.
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