Biostatistical Methodology in Carcinogenicity Studies | Zendy

William R. Fairweather | Zendy; Amit Bhattacharyya | Zendy; Peter Ceuppens | Zendy; Guenter Heimann | Zendy; Ludwig A. Hothorn | Zendy; Ralph L. Kodell | Zendy; Karl K. Lin | Zendy; H. Mager | Zendy; Brian J. Middleton | Zendy; Wout Slob | Zendy; Keith A. Soper | Zendy; Nigel Stallard | Zendy; John Ventre | Zendy; Jane Wright | Zendy

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Biostatistical Methodology in Carcinogenicity Studies

Author(s) -

William R. Fairweather,

Amit Bhattacharyya,

Peter Ceuppens,

Guenter Heimann,

Ludwig A. Hothorn,

Ralph L. Kodell,

Karl K. Lin,

H. Mager,

Brian J. Middleton,

Wout Slob,

Keith A. Soper,

Nigel Stallard,

John Ventre,

Jane Wright

Publication year - 1998

Publication title -

drug information journal

Language(s) - English

Resource type - Journals

eISSN - 2164-9200

pISSN - 0092-8615

DOI - 10.1177/009286159803200212

Subject(s) - context (archaeology) , statistical analysis , computer science , management science , significance testing , pharmaceutical industry , risk analysis (engineering) , data science , medicine , pharmacology , engineering , mathematics , statistics , biology , paleontology

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.

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