Details
| Original language | English |
|---|---|
| Pages (from-to) | 93-98 |
| Number of pages | 6 |
| Journal | Alternatives to laboratory animals |
| Volume | 30 |
| Issue number | SUPPL. 2 |
| Publication status | Published - Dec 2002 |
Abstract
An overview is presented on selected biostatistical aspects of the validation of in vitro toxicological assays. Primarily, the statistical analysis of single assays is discussed. Several approaches are compared for the possible non-monotonic dose - response relationship with a priori unknown shapes. The use of confidence intervals instead of p values for toxicologically appropriate decision making is explained. New methods for demonstrating interlaboratory similarity for dose - response designs are discussed. For validation, the inappropriateness of the concordance coefficient is shown, and sensitivity and specificity, as well as predictive values, are proposed as alternatives. The problem of the missing gold standard is highlighted.
Keywords
- In vitro studies, Interlaboratory studies, Statistics, Validation
ASJC Scopus subject areas
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In: Alternatives to laboratory animals, Vol. 30, No. SUPPL. 2, 12.2002, p. 93-98.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Selected biostatistical aspects of the validation of in vitro toxicological assays
AU - Hothorn, Ludwig A.
PY - 2002/12
Y1 - 2002/12
N2 - An overview is presented on selected biostatistical aspects of the validation of in vitro toxicological assays. Primarily, the statistical analysis of single assays is discussed. Several approaches are compared for the possible non-monotonic dose - response relationship with a priori unknown shapes. The use of confidence intervals instead of p values for toxicologically appropriate decision making is explained. New methods for demonstrating interlaboratory similarity for dose - response designs are discussed. For validation, the inappropriateness of the concordance coefficient is shown, and sensitivity and specificity, as well as predictive values, are proposed as alternatives. The problem of the missing gold standard is highlighted.
AB - An overview is presented on selected biostatistical aspects of the validation of in vitro toxicological assays. Primarily, the statistical analysis of single assays is discussed. Several approaches are compared for the possible non-monotonic dose - response relationship with a priori unknown shapes. The use of confidence intervals instead of p values for toxicologically appropriate decision making is explained. New methods for demonstrating interlaboratory similarity for dose - response designs are discussed. For validation, the inappropriateness of the concordance coefficient is shown, and sensitivity and specificity, as well as predictive values, are proposed as alternatives. The problem of the missing gold standard is highlighted.
KW - In vitro studies
KW - Interlaboratory studies
KW - Statistics
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=0036978503&partnerID=8YFLogxK
U2 - 10.1177/026119290203002s14
DO - 10.1177/026119290203002s14
M3 - Article
C2 - 12513657
AN - SCOPUS:0036978503
VL - 30
SP - 93
EP - 98
JO - Alternatives to laboratory animals
JF - Alternatives to laboratory animals
SN - 0261-1929
IS - SUPPL. 2
ER -