Establishing health-based exposure limits (PDE) for pharmaceutical actives

ToxMinds established, in line with EMA guidance, permitted daily exposures for more than 30 active pharmaceutical ingredients to allow managing any API residues in case of shared facility manufacturing arrangement.

In the context of the regulatory requirement for pharmaceutical companies to establish permitted daily exposures (PDE) for residual actives present in medicinal products as a result of manufacturing of different products in shared facilities, we established for a major pharmaceutical company PDE values for more than 40 actives. As part of this work, we conducted, for each of the actives, a thorough desktop search for available clinical and non-clinical data; reviewed all data including those made available by our client with regard to critical effect and POD study; derived PDE as well OEL’s by application of relevant adjustment factors, and drafted the risk assessment report. All our assessments followed an agreed-upon client template and were in compliance with the respective ICH guidelines.