Skip to content

Commit

Permalink
typo
Browse files Browse the repository at this point in the history
  • Loading branch information
Helmut01 committed Apr 8, 2020
1 parent 6a8d20a commit fe86889
Showing 1 changed file with 1 addition and 1 deletion.
2 changes: 1 addition & 1 deletion vignettes/vignette.Rmd
Original file line number Diff line number Diff line change
Expand Up @@ -25,7 +25,7 @@ library(replicateBE) # attach the library
Version `r packageVersion("replicateBE")` built `r packageDate("replicateBE")` with R `r getRversion()`.\

# Introduction{#intro}
The library provides datasets (internal `.rda` and in <span title="Comma Separated Variables">CSV</span>-format in `/extdata/`) which support users in a [black-box](https://en.wikipedia.org/wiki/Black-box_testing) performance qualification (PQ) of their software installations.^[Schütz H, Tomashevskiy M, Labes D, Shitova A, González-de la Parra M, Fuglsang A. *Reference Data&shy;sets for Studies in a Replicate Design intended for Average Bioequivalence with Expanding Limits.* AAPS J. 2020; 22:44. [doi:10.1208/s12248-020-0427-6](https://doi.org/10.1208/s12248-020-0427-6).] Users can analyze data imported from CSV- and Excel-files.
The library provides datasets (internal `.rda` and in <span title="Comma Separated Variables">CSV</span>-format in `/extdata/`) which support users in a [black-box](https://en.wikipedia.org/wiki/Black-box_testing) performance qualification (PQ) of their software installations.^[Schütz H, Tomashevskiy M, Labes D, Shitova A, González-de la Parra M, Fuglsang A. *Reference Data&shy;sets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits.* AAPS J. 2020; 22:44. [doi:10.1208/s12248-020-0427-6](https://doi.org/10.1208/s12248-020-0427-6).] Users can analyze data imported from CSV- and Excel-files.

The methods given by the European Medicines Agency (EMA) in Annex I^[European Medicines Agency. *Annex I.* London, 21 September 2016. [EMA/582648/2016](https://www.ema.europa.eu/en/documents/other/31-annex-i-statistical-analysis-methods-compatible-ema-bioequivalence-guideline_en.pdf).] for reference-scaling according to the Guideline on the Investigation of Bioequivalence^[European Medicines Agency, Committee for Medicinal Products for Human Use. *Guideline on the Investigation of Bioequivalence.* London, 20 January 2010. [CPMP/EWP/QWP/1401/98 Rev. 1/Corr **](https://www.ema.europa.eu/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf).] are implemented. Potential influence of outliers on the variability of the reference can be assessed by box plots of studentized and standardized residuals as suggested at a joint <span title="European Generic Medicines Association">EGA</span>/EMA symposium.^[European Generic Medicines Association. *Revised EMA Bioequivalence Guideline. *3^rd^ EGA Symposium on Bioequivalence. London, 1 June 2010. [Questions & Answers](https://www.medicinesforeurope.com/wp-content/uploads/2016/03/EGA_BEQ_QA_WEB_QA_1_32.pdf).]

Expand Down

0 comments on commit fe86889

Please sign in to comment.