The synthesis of pharmaceutical products frequently involves the use of reactive reagents and the formation of intermediates and byproducts. Low levels of some of these may be present in the final drug substance and drug product as impurities. Such chemically reactive impurities may have at the same time the potential for unwanted toxicities including genotoxicity and carcinogenicity and hence can have an impact on product risk assessment. The threshold of toxicological concern (TTC) approach for the intake of genotoxic impurities over various periods of exposure has been recently proposed. This staged TTC is based on knowledge about tumorigenic potency of a wide range compounds and can be used for genotoxic compounds, for which cancer data are limited or not available. This approach can be important for certain types of products, such as those for life-threatening indications for which there are no safer alternatives.
|Titolo:||Application of the TTC (Threshold of Toxicological concern) to drug impurities evaluation|
MARINOVICH, MARINA (Primo)
|Data di pubblicazione:||ott-2009|
|Settore Scientifico Disciplinare:||Settore BIO/14 - Farmacologia|
|Citazione:||Application of the TTC (Threshold of Toxicological concern) to drug impurities evaluation / M. Marinovich. ((Intervento presentato al 34. convegno Congresso Nazionale della Società Italiana di Farmacologia tenutosi a Rimini nel 2009.|
|Appare nelle tipologie:||14 - Intervento a convegno non pubblicato|