Regulacje i polityka gospodarcza · 24/11/2008

NICEATM Releases Report on Validation of Alternative Methods for Detecting Pyrogenicity in Pharmaceuticals

The National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) has made available a report on the validation status of five in vitro test methods for assessing potential pyrogenicity of pharmaceuticals and other products. The report concludes that these methods can be used on a case-by-case basis to detect Gram-negative endotoxin in human parenteral drugs, subject to product-specific validation and FDA regulations.