Short communication, Note

Comparison of Two Guidelines on Immunotoxicity Testing of Medicinal Products

Ivana Hanzl Dujmović

Abstract

Despite the lack of formal immunotoxicity testing guidelines, the assessment of immune function has been a routine component of toxicity testing for over twenty years. The European Agency for the Evaluation of Medicinal Products (EMEA) and The US Food and Drug Administration (FDA) have recently adopted new guidelines for immunotoxicity testing of new medicinal products. These two guidelines are compared in this article.

Keywords

drugs; immunotoxicity testing; immunotoxicology; medicinal products; regulatory guidance; tiered testing approach

Hrčak ID:

133

URI

https://hrcak.srce.hr/133

Publication date:

25.7.2005.

Article data in other languages: croatian

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