A note on statistical analysis of organ weights in non-clinical toxicological studies

Toxicology and Applied Pharmacology

Volumn 240, Issue 1, 2009, Pages 117-122

  Wolfsegger, Martin J ^a   Jaki, Thomas ^b   Dietrich, Barbara ^a   Kunzler, Jackie A ^c   Barker, Kerry ^c  

^a BAXTER INNOVATIONS GMBH   (Austria)

^b LANCASTER UNIVERSITY   (United Kingdom)

^c BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Drug toxicity; Organ weights; Risk assessment; Toxicity evaluation method

Indexed keywords

DRUG;

BIOEQUIVALENCE; CONFIDENCE INTERVAL; CONTROLLED STUDY; DECISION TREE; DRUG RESPONSE; EFFECT SIZE; FEMALE; MALE; NONHUMAN; NONPARAMETRIC TEST; ORGAN WEIGHT; RANK SUM TEST; REVIEW; RODENT; STATISTICAL ANALYSIS; TARGET ORGAN; TOXICOLOGY;

ANIMALS; CONFIDENCE INTERVALS; HUMANS; ORGAN SIZE; REPRODUCIBILITY OF RESULTS; STATISTICS AS TOPIC; STATISTICS, NONPARAMETRIC; TOXICOLOGY;

ANIMALIA;

EID: 69549103061     PISSN: 0041008X     EISSN: 10960333     Source Type: Journal    
DOI: 10.1016/j.taap.2009.06.012     Document Type: Review

References (18)

1. Altman D.G., and Bland J.M. Absence of evidence is not evidence of absence. Br. Med. J. (1995) 311-485
2. Altman D.G., Machin D., Bryant T.N., and Gardener M.J. Statistics with Confidence. Brit. Med. J. Books, 2nd ed. (2000), Bristol, JW Arrowsmith Ltd.
3. Bailey S. Subchronic toxicity studies. In: Chow S.C., and Liu J.P. (Eds). Design and Analysis of Animal Studies in Pharmaceutical Development (1998), Marcel Dekker, New York
4. Chow S.C., and Liu J.P. Design and Analysis of Animal Studies in Pharmaceutical Development (1998), Marcel Dekker, New York
5. EMEA/CPMP, 2000. Points to consider on switching between superiority and non-inferiority. London, UK: Committee for Proprietary Medicinal Products. Approval by CPMP: July 2000. CPMP/EWP/482/99.
6. Gad S.C. Statistics for Toxicologists. In: Hayes W. (Ed). Principles and Methods of Toxicology. 4th Edition (2001), Taylor and Francis, Philadelphia
7. Hauschke D., and Hothorn L.A. Safety assessment in toxicological studies: proof of safety versus proof of hazard. In: Chow S.C., and Liu J.P. (Eds). Design and Analysis of Animal Studies in Pharmaceutical Development (1998), Marcel Dekker, New York 197-225
8. Hothorn, T., Munzel, U., 2002. Exact Nonparametric Confidence Intervals for the Ratio of Medians. Technical Report. Friedrich Alexander Universität Erlangen-Nürnberg. URL: http://www.stat.uni-muenchen.de/~hothorn/bib/TH_TR.html; last visited on 2009-06-08.
9. Hsu J.C. Multiple Comparisons. Theory and Methods (1996), Chapman and Hall, London
10. Hsu J.C., and Berger R.L. Stepwise confidence intervals without multiplicity adjustment for dose-response and toxicity studies. J. Am. Stat. Assoc. 94 446 (1999) 468-482
11. Kolmogorov A.N. Sulla determinazione empirica di una legge di distribuzione. Giron. Inst. Ital. Att. 4 (1933) 83-91
12. Michael B., Yano B., Sellers R.S., Perry R., Morton D., Roome N., Johnson J.K., and Schafer K. Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices. Toxicol. Pathol. 35 (2007) 742-750
13. Neter J., Kutner M., Wasserman W., and Nachtsheim C. Applied Linear Statistical Models, 4th Edition (1996), McGraw-Hill, Boston
14. O'Brien P.C. Procedures for comparing samples with multiple endpoints. Biometrics 40 (1984) 1079-1087
15. R Development Core Team, 2009. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing. Vienna, Austria. URL: http://www.r-project.org.
16. Schaarschmidt, F., Gerhard, D., 2008. PairwiseCI: Confidence intervals for two sample comparisons. R package version 0.1-15.
17. Sellers R.S., Morton D., Michael B., Roome N., Johnson J.K., Yano B.L., Perry R., and Schafer K. Society of Toxicologic Pathology position paper: organ weight recommendations for toxicology studies. Toxicol. Pathol. 35 (2007) 751-755
18. Smirnov N.V. On the estimation of the discrepancy between empirical curves of distribution for two independent samples. (Russian) Math. Bull. Moscow Univ. 2 (1939) 3-16