In recent years we have experienced a considerable increase in demand for our services from those operating in the pharmaceutical sector. We consider ourselves the regulatory professional’s ideal partner when the knowledge required goes beyond the specifics of a particular regulation or guideline into the more nuanced territory concerned with risk assessment.
Our advice is regularly sought on the toxicological risks posed by non-active substances present in pharmaceuticals. Bibra’s scientists are experts in identifying existing relevant information on toxicity and metabolism. While toxicity data may be plentiful for excipients and certain leachables, they are often insufficient or absent for impurities, making bibra’s expertise invaluable in the application of Structure Activity Relationship (SAR) considerations and the Threshold of Toxicological Concern (TTC) concepts.
Genotoxic or potentially genotoxic impurities and contaminants can pose a particular challenge to risk assessment, and bibra can apply EMA/ICH guidance and make best use of the TTC concept.
Pharmaceuticals are administered by various routes including intravenous injection, by mouth, by inhalation or dermally. Bibra is experienced in the application of available data (often generated by the oral route) to other routes of administration.