According to the ICH M7(R1) guideline, a preliminary analysis of actual and potential impurities should be done by searching the database and literature on bacteria’s carcinogenicity and mutagenicity.
The QSAR Lab offer includes read-across and determination of TD50 and AI values for the substance defined by a client (compound name/compound CAS number).
The report includes:
- detailed documentation on the methodology of searching for analogs for a defined compound,
- SAR similarity analysis for selected analogs and a defined compound,
- the estimated TD50 value for the defined compound based on the selected analog(s),
- assessment of source publications on the carcinogenicity of analogs used to determine the TD50 value in terms of the quality of each of the studies performed and its results (e.g., compliance with OECD guidelines, GLP system, etc.)