Biostatistical methodology in carcinogenicity studies

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

doi:10.1177/009286159803200212

Biostatistical methodology in carcinogenicity studies

William R. Fairweather^*
, Amit Bhattacharyya
, Peter P. Ceuppens
, Guenter Heimann
, Ludwig A. Hothorn
, Ralph L. Kodell
, Karl K. Lin
, Harry Mager
, Brian J. Middleton
, Wout Slob
, Keith A. Soper
, Nigel Stallard
, John Ventre
, Jane Wright

^*Korrespondierende*r Autor*in für diese Arbeit

Abteilung Biostatistik

Publikation: Beitrag in Fachzeitschrift › Artikel › Forschung › Peer-Review

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.

Originalsprache	Englisch
Seiten (von - bis)	401-421
Seitenumfang	21
Fachzeitschrift	Therapeutic Innovation & Regulatory Science
Jahrgang	32
Ausgabenummer	2
DOIs	https://doi.org/10.1177/009286159803200212 https://doi.org/10.15488/2987
Publikationsstatus	Veröffentlicht - 30 Dez. 1998

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ASJC Scopus Sachgebiete

Pharmakologie, Toxikologie und Pharmazie (sonstige)
Öffentliche Gesundheit, Umwelt- und Arbeitsmedizin
Pharmakologie (medizinische)

Zugriff auf Dokument

10.1177/009286159803200212
10.15488/2987Lizenz: Sonstige

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Fairweather, W. R., Bhattacharyya, A., Ceuppens, P. P., Heimann, G., Hothorn, L. A., Kodell, R. L., Lin, K. K., Mager, H., Middleton, B. J., Slob, W., Soper, K. A., Stallard, N., Ventre, J., & Wright, J. (1998). Biostatistical methodology in carcinogenicity studies. Therapeutic Innovation & Regulatory Science, 32(2), 401-421. https://doi.org/10.1177/009286159803200212, https://doi.org/10.15488/2987

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title = "Biostatistical methodology in carcinogenicity studies",

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.",

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month = dec,

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doi = "10.1177/009286159803200212",

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Fairweather, WR, Bhattacharyya, A, Ceuppens, PP, Heimann, G, Hothorn, LA, Kodell, RL, Lin, KK, Mager, H, Middleton, BJ, Slob, W, Soper, KA, Stallard, N, Ventre, J & Wright, J 1998, 'Biostatistical methodology in carcinogenicity studies', Therapeutic Innovation & Regulatory Science, Jg. 32, Nr. 2, S. 401-421. https://doi.org/10.1177/009286159803200212, https://doi.org/10.15488/2987

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AU - Fairweather, William R.

AU - Bhattacharyya, Amit

AU - Ceuppens, Peter P.

AU - Heimann, Guenter

AU - Hothorn, Ludwig A.

AU - Kodell, Ralph L.

AU - Lin, Karl K.

AU - Mager, Harry

AU - Middleton, Brian J.

AU - Slob, Wout

AU - Soper, Keith A.

AU - Stallard, Nigel

AU - Ventre, John

AU - Wright, Jane

PY - 1998/12/30

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KW - Literature

KW - Study design

KW - Test statistics

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