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Preclinical assessments of european union marketing authorisation applications for immunomodulatory biopharmaceuticals.

Authors
  • Liminga, U
Type
Published Article
Journal
Human & experimental toxicology
Publication Date
Apr 01, 2000
Volume
19
Issue
4
Pages
257–260
Identifiers
PMID: 10918519
Source
Medline
License
Unknown

Abstract

A review of preclinical assessment reports on immunomodulatory biopharmaceuticals submitted to the European Agency for Evaluation of Medicinal Products from 1995 to the middle of 1999 was conducted. Questions regarding the rationale for the preclinical development programmes were often put to the applicants. Effects mediated via changes of the immune function, including risks of reproductive toxicity and tumorigenicity, were of particular concern. This review indicates the need to further develop methods for safety testing of immunomodulatory biopharmaceuticals.

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