Action limit outlier test: a novel approach for the identification of outliers in bioassay dose-response curves.
| Autor: | Solzin J; Boehringer Ingelheim Pharma GmbH & Co KG Biberach, 88400 Biberach an der Riß, Germany., Buchner H; Staburo GmbH, 81549 Munich, Germany., Berger A; Boehringer Ingelheim Pharma GmbH & Co KG Biberach, 88400 Biberach an der Riß, Germany., Reidy R; Staburo GmbH, 81549 Munich, Germany., Boehrer A; Boehringer Ingelheim Pharma GmbH & Co KG Biberach, 88400 Biberach an der Riß, Germany., Bluhmki E; Boehringer Ingelheim Pharma GmbH & Co KG Biberach, 88400 Biberach an der Riß, Germany.; Hochschule Biberach, University of Applied Sciences, 88400 Biberach an der Riß, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | Bioanalysis [Bioanalysis] 2020 Oct; Vol. 12 (20), pp. 1459-1468. Date of Electronic Publication: 2020 Oct 07. |
| DOI: | 10.4155/bio-2020-0189 |
| Abstrakt: | Aim/Materials & methods: Guidelines like United States Pharmacopeia 1032 [1] and pharm.Eur. [2] acknowledge that cell-based bioassays are complex methods and thus prone to outliers. However, investigations into root causes of outliers are often inconclusive. We have established a procedure (including quality control and documentation) implemented in a freely available software application which includes not only the experience of the analyst but also information of historical data. Results: This action limit outlier test is unique to our knowledge. Action limit outlier test allows the determination of outliers efficiently which lead to a significant reduction of false positives in comparison with the traditional outlier test ROUT [3] or Rosner [4] alone as shown by our simulated data (58 and 44% reduction of false positives for ROUT and Rosner, respectively). |
| Databáze: | MEDLINE |
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