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NEW ASSAY

We increased area of our in vitro servises. New assay by OECD 442D In Vitro Skin Sensitisation (ARE reporter gene assay) is cell based animal free test.

 Ames Test for Genotoxic Impurities – ICH M7 

The Ames MPF and Ames II kits are two microsystems cited in the ICH M7 guideline for genotoxic impurities and are preferred by the pharmaceutical industry due to their low consumption of compound and high sensitivity. In addition, the kit system offers additional advantages such as significant less hands on time and possibilities for automation, less contaminated waste and thus less environmental pollution. Up to 12 x less rat liver S9 follows the 3Rs philosophy reducing test animals.

For more information read on:

New Guideline M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Please see our presentation