Details
| Original language | English |
|---|---|
| Pages (from-to) | 915-933 |
| Number of pages | 19 |
| Journal | Journal of Biopharmaceutical Statistics |
| Volume | 18 |
| Issue number | 5 |
| Publication status | Published - 10 Sept 2008 |
Abstract
Simultaneous confidence interval for differences or ratios to control are described for both the proof of hazard and the proof of safety for the typical design in toxicology including several doses and a control. For most endpoints the direction of harmfulness is a priori known; therefore one-sided confidence intervals for Gaussian distributed endpoints, proportions, and poly-k-adjusted tumor rates are used. Special packages in the software R are provided to estimate these confidence intervals. Real data examples are given to demonstrate the estimation of the confidence intervals and their interpretation for selected toxicological studies.
Keywords
- Proof of hazard, Proof of safety, Regulatory toxicology, Simultaneous confidence intervals
ASJC Scopus subject areas
- Mathematics(all)
- Statistics and Probability
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology
- Medicine(all)
- Pharmacology (medical)
Cite this
- Standard
- Harvard
- Apa
- Vancouver
- BibTeX
- RIS
In: Journal of Biopharmaceutical Statistics, Vol. 18, No. 5, 10.09.2008, p. 915-933.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Proof of hazard and proof of safety in toxicological studies using simultaneous confidence intervals for differences and ratios to control
AU - Hothorn, Ludwig A.
AU - Hasler, Mario
N1 - Funding Information: Received October 1, 2007; Accepted March 13, 2008 Parts of the presented work were supported by the EC grant EU-2006/S237-252824 ANOVA technique for ratios. Address correspondence to Ludwig A. Hothorn, Institute of Biostatistics, Leibniz University Hannover, Herrenhaeuser Str. 2, D-30419 Hannover, Germany; E-mail: hothorn@biostat.uni-hannover.de
PY - 2008/9/10
Y1 - 2008/9/10
N2 - Simultaneous confidence interval for differences or ratios to control are described for both the proof of hazard and the proof of safety for the typical design in toxicology including several doses and a control. For most endpoints the direction of harmfulness is a priori known; therefore one-sided confidence intervals for Gaussian distributed endpoints, proportions, and poly-k-adjusted tumor rates are used. Special packages in the software R are provided to estimate these confidence intervals. Real data examples are given to demonstrate the estimation of the confidence intervals and their interpretation for selected toxicological studies.
AB - Simultaneous confidence interval for differences or ratios to control are described for both the proof of hazard and the proof of safety for the typical design in toxicology including several doses and a control. For most endpoints the direction of harmfulness is a priori known; therefore one-sided confidence intervals for Gaussian distributed endpoints, proportions, and poly-k-adjusted tumor rates are used. Special packages in the software R are provided to estimate these confidence intervals. Real data examples are given to demonstrate the estimation of the confidence intervals and their interpretation for selected toxicological studies.
KW - Proof of hazard
KW - Proof of safety
KW - Regulatory toxicology
KW - Simultaneous confidence intervals
UR - http://www.scopus.com/inward/record.url?scp=51649090660&partnerID=8YFLogxK
U2 - 10.1080/10543400802287511
DO - 10.1080/10543400802287511
M3 - Article
C2 - 18781525
AN - SCOPUS:51649090660
VL - 18
SP - 915
EP - 933
JO - Journal of Biopharmaceutical Statistics
JF - Journal of Biopharmaceutical Statistics
SN - 1054-3406
IS - 5
ER -