Details
| Original language | English |
|---|---|
| Pages (from-to) | 403-412 |
| Number of pages | 10 |
| Journal | Therapeutic Innovation & Regulatory Science |
| Volume | 31 |
| Issue number | 2 |
| Publication status | Published - 30 Dec 1997 |
Abstract
A Drug Information Association Workshop on “Statistical Methodology on Non-Clinical and Toxicological Studies” was held on March, 25-27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper proposes a simple closure test for dose-response relationships under real data conditions. This approach takes into account deviation from variance homogeneity and monotonicity assumptions. Moreover, this approach can be easily adapted for “any” kind of two-sample tests, for example, nonparametric, dichotomous, censored, and so forth. Power was compared by a simulation study for selected conditions.
Keywords
- Closure principle, MED, Toxicological studies, Trend test
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Medicine(all)
- Public Health, Environmental and Occupational Health
- Medicine(all)
- Pharmacology (medical)
Sustainable Development Goals
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In: Therapeutic Innovation & Regulatory Science, Vol. 31, No. 2, 30.12.1997, p. 403-412.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Modifications of the closure principle for analyzing toxicological studies
AU - Hothorn, Ludwig A.
PY - 1997/12/30
Y1 - 1997/12/30
N2 - A Drug Information Association Workshop on “Statistical Methodology on Non-Clinical and Toxicological Studies” was held on March, 25-27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper proposes a simple closure test for dose-response relationships under real data conditions. This approach takes into account deviation from variance homogeneity and monotonicity assumptions. Moreover, this approach can be easily adapted for “any” kind of two-sample tests, for example, nonparametric, dichotomous, censored, and so forth. Power was compared by a simulation study for selected conditions.
AB - A Drug Information Association Workshop on “Statistical Methodology on Non-Clinical and Toxicological Studies” was held on March, 25-27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper proposes a simple closure test for dose-response relationships under real data conditions. This approach takes into account deviation from variance homogeneity and monotonicity assumptions. Moreover, this approach can be easily adapted for “any” kind of two-sample tests, for example, nonparametric, dichotomous, censored, and so forth. Power was compared by a simulation study for selected conditions.
KW - Closure principle
KW - MED
KW - Toxicological studies
KW - Trend test
UR - http://www.scopus.com/inward/record.url?scp=84993709289&partnerID=8YFLogxK
U2 - 10.1177/009286159703100211
DO - 10.1177/009286159703100211
M3 - Article
AN - SCOPUS:84993709289
VL - 31
SP - 403
EP - 412
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
SN - 2168-4790
IS - 2
ER -