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Current status and burning issues in immunotoxicity testing of drugs.

Abstract：

:Besides pathology endpoints, additional immune function endpoints have been included in the Note for Guidance on Repeated Dose Toxicity by the European Union (July 2001), which concern the analysis of antibody responses to a T-cell-dependent antigen. Guidance papers of other regulatory authorities are published as well. The main issue is the need for functional immunotoxicity testing to detect unintended immunosuppression. The International Conference on Harmonization (ICH) has surveyed studies from the files of the pharmaceutical industry to find the proportion of compounds that can be detected by additional immunotoxicity testing. Preliminary analysis shows that 10-15% of the compounds in the survey only react positively to the additional tests. More data are requested from the pharmaceutical industry. The Expert Working Group of the ICH has decided to choose a cause-for-concern approach to immunotoxicity rather than a routine-screening approach. The causes for concern are to be defined during ICH negotiations.

journal_name

Toxicol Appl Pharmacol

journal_title

Toxicology and applied pharmacology

authors

van der Laan JW,van Loveren H

doi

10.1016/j.taap.2005.02.030

subject

Has Abstract

pub_date

2005-09-01 00:00:00

pages

435-40

issue

2 Suppl

eissn

0041-008X

issn

1096-0333

pii

S0041-008X(05)00299-1

journal_volume

207

pub_type

杂志文章,评审

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