FEMA expert panel review of p -mentha-1,8-dien-7-al genotoxicity testing results

FEMA expert panel review of p-mentha-1,8-dien-7-al genotoxicity testing results.

p-Mentha-1,8-dien-7-al is a naturally occurring cyclic alpha,beta-unsaturated aldehyde that is used as a flavoring substance throughout the world. Due to the chemical structure and the potential DNA reactivity of the alpha,beta-unsaturated carbonyl moiety, a battery of genotoxicity assays was requested by the European Food Safety Authority. Previous genotoxicity studies on the substance gave mi...

Genotoxicity Testing: a Review

Genotoxicity is a major limitation of various compounds used in clinical practices which range from gene mutations, chromosomal aberrations to other DNA effects. For the same reason, it must be assessed before bringing into the market. Moreover, various regulatory agencies have made it mandatory to submit the genotoxicity data while filing a New Drug Application (NDA). This in turn has given fu...

Budd-Chiari syndrome: a review by an expert panel.

Harry L.A. Janssen*, Juan-Carlos Garcia-Pagan, Elwyn Elias, Gilles Mentha, Antoine Hadengue, Dominique-Charles Valla, for the European Group for the Study of Vascular Disorders of the Liver Department of Gastroenterology and Hepatology, University Hospital Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clinic, Barcelona, Spain ...

Expert Panel Report

High-Throughput Genotoxicity Testing

The registration of all pharmaceuticals requires a comprehensive safety assessment of their potential to cause direct or indirect genotoxic damage. This article reviews current methods employed for regulatory genotoxicity testing and new techniques developed for early high-throughput screening. A novel in vitro mammalian assay is described which detects all common mechanistic classes of genotox...