Biostatistical methodology in carcinogenicity studies

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dc.identifier.uri Fairweather, William R. Bhattacharyya, Amit Ceuppens, Peter P. Heimann, Günter Hothorn, Ludwig A. Kodell, Ralph L. Lin, Karl K. Mager, Harry Middleton, Brian J. Slob, Wout Soper, Keith A. Stallard, Nigel Ventre, John Wright, Jane 2018-02-28T13:27:47Z 2018-02-28T13:27:47Z 1998
dc.identifier.citation Fairweather, W.R.; Bhattacharyya, A.; Ceuppens, P.P.; Heimann, G.; Hothorn, L.A. et al.: Biostatistical methodology in carcinogenicity studies. In: Therapeutic Innovation & Regulatory Science 32 (1998), Nr. 2, S. 401-421. DOI:
dc.description.abstract This paper addresses the design, conduct, and statistical analysis of carcinogenicity studies, especially in the context of drug products for human use. It contains suggestions concerning the choice of dose levels, number of animals, methods of slide reading, and the ensuing statistical analysis, focusing on the significance testing approach. The purpose of this document is to describe the current thinking of statisticians and others who work in the area of carcinogenicity studies. The authors represent experience gained in the pharmaceutical industry, regulatory agencies, and academia. © 1998, Drug Information Association. All rights reserved. eng
dc.language.iso eng
dc.publisher London : SAGE Publications Ltd.
dc.relation.ispartofseries Therapeutic Innovation & Regulatory Science 32 (1998), Nr. 2
dc.rights Es gilt deutsches Urheberrecht. Das Dokument darf zum eigenen Gebrauch kostenfrei genutzt, aber nicht im Internet bereitgestellt oder an Außenstehende weitergegeben werden. Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
dc.subject Carcinogenicity eng
dc.subject Data analysis eng
dc.subject Literature eng
dc.subject Study design eng
dc.subject Test statistics eng
dc.subject.ddc 610 | Medizin, Gesundheit ger
dc.title Biostatistical methodology in carcinogenicity studies eng
dc.type article
dc.type Text
dc.relation.issn 2168-4790
dc.bibliographicCitation.issue 2
dc.bibliographicCitation.volume 32
dc.bibliographicCitation.firstPage 401
dc.bibliographicCitation.lastPage 421
dc.description.version publishedVersion
tib.accessRights frei zug�nglich

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