Details
| Original language | English |
|---|---|
| Pages (from-to) | 186-193 |
| Number of pages | 8 |
| Journal | Journal of Pharmaceutical and Biomedical Analysis |
| Volume | 74 |
| Early online date | 5 Nov 2012 |
| Publication status | Published - 23 Feb 2013 |
Abstract
After assay validation in an originating laboratory, an analytical method needs to be transferred to one or several production laboratories, because measured outcomes among the laboratories must agree. To state agreement, the locations (e.g. means) must be equivalent and the production laboratory must be non-inferior to the originating one concerning scales (e.g. standard deviations). Here, parametric and non-parametric approaches based on marginal confidence intervals for the ratio of locations and the ratio of scales are presented. These intervals are appropriate for a matched pairs design without repeated measurements. Results of simulation studies investigating the power and the control of the type I error are shown and limits of the approaches are discussed. In addition, a Bland-Altman plot with tolerance intervals is proposed. As illustrated in the example proportional differences greatly improve the interpretation of the results compared to absolute differences.
Keywords
- Location-scale approach, Method transfer, Relative acceptance bound, Tolerance interval
ASJC Scopus subject areas
- Chemistry(all)
- Analytical Chemistry
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmaceutical Science
- Pharmacology, Toxicology and Pharmaceutics(all)
- Drug Discovery
- Chemistry(all)
- Spectroscopy
- Biochemistry, Genetics and Molecular Biology(all)
- Clinical Biochemistry
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In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 74, 23.02.2013, p. 186-193.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Analytical method transfer
T2 - Improving interpretability with ratio-based statistical approaches
AU - Frömke, C.
AU - Hothorn, L. A.
AU - Sczesny, F.
AU - Onken, J.
AU - Schneider, M.
PY - 2013/2/23
Y1 - 2013/2/23
N2 - After assay validation in an originating laboratory, an analytical method needs to be transferred to one or several production laboratories, because measured outcomes among the laboratories must agree. To state agreement, the locations (e.g. means) must be equivalent and the production laboratory must be non-inferior to the originating one concerning scales (e.g. standard deviations). Here, parametric and non-parametric approaches based on marginal confidence intervals for the ratio of locations and the ratio of scales are presented. These intervals are appropriate for a matched pairs design without repeated measurements. Results of simulation studies investigating the power and the control of the type I error are shown and limits of the approaches are discussed. In addition, a Bland-Altman plot with tolerance intervals is proposed. As illustrated in the example proportional differences greatly improve the interpretation of the results compared to absolute differences.
AB - After assay validation in an originating laboratory, an analytical method needs to be transferred to one or several production laboratories, because measured outcomes among the laboratories must agree. To state agreement, the locations (e.g. means) must be equivalent and the production laboratory must be non-inferior to the originating one concerning scales (e.g. standard deviations). Here, parametric and non-parametric approaches based on marginal confidence intervals for the ratio of locations and the ratio of scales are presented. These intervals are appropriate for a matched pairs design without repeated measurements. Results of simulation studies investigating the power and the control of the type I error are shown and limits of the approaches are discussed. In addition, a Bland-Altman plot with tolerance intervals is proposed. As illustrated in the example proportional differences greatly improve the interpretation of the results compared to absolute differences.
KW - Location-scale approach
KW - Method transfer
KW - Relative acceptance bound
KW - Tolerance interval
UR - http://www.scopus.com/inward/record.url?scp=84871741984&partnerID=8YFLogxK
U2 - 10.1016/j.jpba.2012.10.032
DO - 10.1016/j.jpba.2012.10.032
M3 - Article
C2 - 23245250
AN - SCOPUS:84871741984
VL - 74
SP - 186
EP - 193
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
SN - 0731-7085
ER -