Estimation of TD50 and Acceptable Intake (AI) values of nitrosamines
Estimation of TD50 and Acceptable Intake (AI) values of nitrosamines Estimation of TD50 (50% Tumor Dose) and Acceptable Intake (AI) values of nitrosamines as impurities in medicinal products based on read-across methodology. According to the ICH M7(R1) guideline, a preliminary analysis of actual and potential impurities should be done by searching the database and literature […]