IN SILICO TOXICOLOGY ASSESSMENT

RD&C offers in silico toxicology assessments for drug molecules, impurities, degradants, metabolites and any other chemical compounds including extensive literature analysis and data evaluation for multiple purposes (e. g. ERA, REACH, impurity profiling, etc.)

Calculation of Permitted Daily Exposure (PDE) and concentration limits

RD&C offers calculation and evaluation of PDE for elemental impurities according to ICH Q3D including proposals for assessment of purification procedures, in-process controls, material and excipient specification, selection of appropriate container closure systems, and specification limits for drug substance and drug product.

Discussion of Threshold of Toxicological Concern (TTC)

RD&C offers analysis and evaluation of TTC according to ICH M7 for (potential) mutagenic impurities including in silico methods and purge factor discussions. Additionally, a risk assessment report and a concept for control stratgies will be developed and implemented.