Chemical Toxicology in the Pharmaceutical Industry

Raphael Nudelman, Non Clinical Safety, Teva Pharmaceticals, Netanya, Israel

The use of pharmaceuticals is always a balance of risks and benefits. This is not true for impurities in pharmaceuticals. Impurities convey only potential risk. Regional and international agencies have developed guidelines and guidances instructing drug developers and regulatory agencies on how to evaluate and control impurities in drug substances (active pharmaceutical ingredients) and drug products (formulated drugs). While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This lecture will give an overview of the practical and theoretical methods used for qualification of different classes of impurities.