Current status and use of short/medium term models for carcinogenicity testing of pharmaceuticals--scientific perspective.

Abstract:

:Short- and medium-term rodent bioassays have been proposed under ICH guidelines for use in testing for the carcinogenic potential of pharmaceuticals. Further evaluation of these models is needed urgently and coordinated efforts are in progress worldwide to expand the available database. Models currently being investigated include transgenic mice (Tg-rasH2, Tg.AC, p53(+/-), XPA(-/-)) and neonatal mice. As more data become available on the performance of these assays, regulatory and industry scientists will be faced with the difficult challenge of determining how the performance (accuracy) of each assay will be measured and deciding which assays have value in the risk assessment process.

journal_name

Toxicol Lett

journal_title

Toxicology letters

authors

Storer RD

doi

10.1016/s0378-4274(99)00227-1

keywords:

subject

Has Abstract

pub_date

2000-03-15 00:00:00

pages

557-66

eissn

0378-4274

issn

1879-3169

pii

S0378427499002271

journal_volume

112-113

pub_type

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