Search results - 5 results

Hazard characterization of Alternaria toxins to identify data gaps and improve risk assessment for human health.

quinones altertoxin I (ATX-I), ATX- II, ATX- III, alterperylenol (ALP), and stemphyltoxin III (STTX- III) showed in vitro genotoxic and mutagenic properties. Of all identified Alternaria toxins, the ...

Pyrogen testing of phage therapeutic products

is pivotal to limit the risk of non-endotoxin contamination. These pyrogens can be detected by the monocyte activation test (MAT), which employs human blood cells to quantify pyrogenicity in vitro. In ...

Novel prediction models for genotoxicity based on biomarker genes in human HepaRG™ cells.

towards a more human-relevant in vitro genotoxicity testing strategy without the use of experimental animals. Health Topics:  Health and environment Santé et environnement Gezondheid en milieu Service:  ...

Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.

techniques to measure critical quality attributes. However, introduction of in vitro alternatives to replace in vivo release assays of authorized vaccines is challenging. AREAS COVERED: This report describes ...

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