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 carcinogenicity and mutagenicity on bacteria.
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 analogues for a defined compound,
- SAR similarity analysis for selected analogues and a defined compound,
- the estimated TD50 value for the defined compound based on the selected analog(s),
- assessment of source publications on carcinogenicity of analogues used to determine the TD50 value in terms of the quality of each of the study performed and its results (e.g. compliance with OECD guidelines, GLP system, etc.)