Genotoxicity testing of herbal medicinal products (HMPs) or similar plant preparations

You need Genotoxicity testing for well-established or traditional herbal medicinal products (HMPs) or similar herbal substances/preparations, plant extracts? LAUS can help.

EMA has described a pragmatic approach for genotoxicity testing and the special needs of HMPs within the current regulatory framework applicable for these products*. They require:

Step 1: The Ames test acc. to the ICH guidelines

Step 2: In vitro Mouse lymphoma assay or other mammalian cell assay (if the Ames test is not unequivocally negative)

HMPs are complex mixtures and may pose technical difficulties for their reliable genotoxicity assessment. LAUS has long time experience with these tests and our experts will be available to discuss how to address the challenges of those complex mixtures.

*GUIDELINE ON THE ASSESSMENT OF GENOTOXICITY OF HERBAL SUBSTANCES/PREPARATIONS Doc. Ref. EMEA/HMPC/107079/2007

https://www.laus.group/en/mutagenicity-genotoxicity/

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