Biomaterial Database

An alternative approach to the analysis of animal carcinogenicity studies. 1996

N Stallard, and A Whitehead

Medical and Pharmaceutical Statistics Research Unit, University of Reading, Reading, RG6 6FN, United Kingdom.

Long-term animal carcinogenicity studies are an important part of the risk analysis process assessing the carcinogenic potential of products to humans. Results from the statistical analysis of the data from such studies are generally presented as a series of hypothesis tests indicating whether there was a significant rise in the number of tumors at given sites. The conclusion from such an analysis depends on the size of the experiment. In particular, the number of false-negative results can be high when tumors are rare. In this paper, a test for equivalence fixing the proportion of false negatives is proposed. The effect on the required sample size is also discussed.

UI	MeSH Term	Description	Entries
D009374	Neoplasms, Experimental	Experimentally induced new abnormal growth of TISSUES in animals to provide models for studying human neoplasms.	Experimental Neoplasms,Experimental Neoplasm,Neoplasm, Experimental
D002273	Carcinogens	Substances that increase the risk of NEOPLASMS in humans or animals. Both genotoxic chemicals, which affect DNA directly, and nongenotoxic chemicals, which induce neoplasms by other mechanism, are included.	Carcinogen,Oncogen,Oncogens,Tumor Initiator,Tumor Initiators,Tumor Promoter,Tumor Promoters,Initiator, Tumor,Initiators, Tumor,Promoter, Tumor,Promoters, Tumor
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D000826	Animal Testing Alternatives	Procedures, such as TISSUE CULTURE TECHNIQUES; mathematical models; etc., when used or advocated for use in place of the use of animals in research or diagnostic laboratories.	Alternatives to Animal Testing,Alternative, Animal Testing,Alternatives, Animal Testing,Animal Testing Alternative,Testing Alternative, Animal,Testing Alternatives, Animal
D000830	Animals, Laboratory	Animals used or intended for use in research, testing, or teaching.	Laboratory Animals,Animal, Laboratory,Laboratory Animal
D013223	Statistics as Topic	Works about the science and art of collecting, summarizing, and analyzing data that are subject to random variation.	Area Analysis,Estimation Technics,Estimation Techniques,Indirect Estimation Technics,Indirect Estimation Techniques,Multiple Classification Analysis,Service Statistics,Statistical Study,Statistics, Service,Tables and Charts as Topic,Analyses, Area,Analyses, Multiple Classification,Area Analyses,Classification Analyses, Multiple,Classification Analysis, Multiple,Estimation Technic, Indirect,Estimation Technics, Indirect,Estimation Technique,Estimation Technique, Indirect,Estimation Techniques, Indirect,Indirect Estimation Technic,Indirect Estimation Technique,Multiple Classification Analyses,Statistical Studies,Studies, Statistical,Study, Statistical,Technic, Indirect Estimation,Technics, Estimation,Technics, Indirect Estimation,Technique, Estimation,Technique, Indirect Estimation,Techniques, Estimation,Techniques, Indirect Estimation
D018401	Sample Size	The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95)	Sample Sizes,Size, Sample,Sizes, Sample
D018675	Toxicity Tests	An array of tests used to determine the toxicity of a substance to living systems. These include tests on clinical drugs, foods, and environmental pollutants.	Tests, Toxicity,Test, Toxicity,Toxicity Test