Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions

被引：69

作者：

Keenan, Charlotte ^{[1
]}

Elmore, Susan ^{[2
]}

Francke-Carroll, Sabine ^{[3
]}

Kemp, Ramon ^{[4
]}

Kerlin, Roy ^{[5
]}

Peddada, Shyamal

Pletcher, John ^{[6
]}

Rinke, Matthias ^{[7
]}

Schmidt, Stephen Peter ^{[5
]}

Taylor, Ian

Wolf, Douglas C. ^{[8
]}

机构：

[1] GlaxoSmithKline Inc, King Of Prussia, PA 19406 USA

[2] NIEHS, Natl Toxicol Program, Res Triangle Pk, NC 27709 USA

[3] US FDA, CFSAN, College Pk, MD USA

[4] Merck Res Labs, Riom, France

[5] Pfizer Inc, Groton, CT 06340 USA

[6] Charles River, Frederick, MD USA

[7] Bayer Schering Pharma AG, Wuppertal, Germany

[8] US EPA, Res Triangle Pk, NC 27711 USA

来源：

TOXICOLOGIC PATHOLOGY | 2009年 / 37卷 / 05期

关键词：

historical control data; rodent tumors; carcinogenicity studies; best practices; NATIONAL TOXICOLOGY PROGRAM; SPRAGUE-DAWLEY RATS; DUAL CONTROL-GROUPS; WISTAR RATS; BODY-WEIGHT; SPONTANEOUS TUMORS; B6C3F1; MICE; JOINT PUBLICATION; REVISED GUIDES; NACAD GROUPS;

D O I：

10.1177/0192623309336154

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

In conclusion, when evaluating proliferative lesions from nonclinical rodent carcinogenicity studies, the concurrent control group is the most relevant. However, when the biological significance of a change in incidence of proliferative lesions in compound-treated groups relative to concurrent controls is uncertain, historical control data can aid in the overall evaluation. When using HCD, several issues should be taken into consideration such as source and quality of HCD, in-life and postmortem factors associated with the origination of the HCD, and type of statistical tools used to present the HCD, which reflect the consensus principles summarized by the HCD Working Group. copyright © 2009 by the author(s).

引用

页码：679 / 693

页数：15

共 114 条

[1] FDA points-to-consider documents: The need for dietary control for the reduction of experimental variability within animal assays and the use of dietary restriction to achieve dietary control [J].

Allaben, WT ;

Turturro, A ;

Leakey, JEA ;

Seng, JE ;

Hart, RW .

TOXICOLOGIC PATHOLOGY, 1996, 24 (06) :776-781

[2]

AMDUR MO, 1991, CASARETT DOULLS TOXI, P165

[3]

[Anonymous], 453 OECD

[4] Neoplastic and non-neoplastic lesions in the mammary gland, endocrine and genital organs in aging male and female Sprague-Dawley rats [J].

Attia, MA .

ARCHIVES OF TOXICOLOGY, 1996, 70 (08) :461-473

[5] Carcinogenicity evaluation: Comparison of tumor data from dual control groups in the Sprague-Dawley rat [J].

Baldrick, P .

TOXICOLOGIC PATHOLOGY, 2005, 33 (02) :283-291

[6] Carcinogenicity evaluation: Comparison of tumor data from dual control groups in the CD-1 mouse [J].

Baldrick, Paul ;

Reeve, Lesley .

TOXICOLOGIC PATHOLOGY, 2007, 35 (04) :562-569

[7] Environmental enrichment lowers stress-responsive hormones in singly housed male and female rats [J].

Belz, EE ;

Kennell, JS ;

Czambel, RK ;

Rubin, RT ;

Rhodes, ME .

PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR, 2003, 76 (3-4) :481-486

[8]

BLACK HE, 1991, TOXICOL PATHOL, V19, P290

[9] Transponder-induced sarcoma in the heterozygous p53+/- mouse [J].

Blanchard, KT ;

Barthel, C ;

French, JE ;

Holden, HE ;

Moretz, R ;

Pack, FD ;

Tennant, RW ;

Stoll, RE .

TOXICOLOGIC PATHOLOGY, 1999, 27 (05) :519-527

[10] FREQUENCY OF SPONTANEOUS TUMORS IN WISTAR RATS IN 30-MONTHS STUDIES [J].

BOMHARD, E .

EXPERIMENTAL AND TOXICOLOGIC PATHOLOGY, 1992, 44 (07) :381-392

← 1 2 3 4 5 6 7 8 9 10 →