Considerations for Deriving Health-Based Exposure Limits for Active Pharmaceutical Ingredients

In June 2015, a guideline published by the European Medicines Agency came into force (EMA/CHMP/CVMP/SWP/169430/2012). This guideline outlines requirements and methods for establishing health-based exposure limits for active pharmaceutical ingredients (APIs) related to carryover contamination of one API into another API or drug product. The health-based exposure limit is referred to as the permitted daily exposure (PDE) value, and its derivation requires consideration of toxicology/safety data, pharmacology (efficacy) data, the route(s) of exposure, and other information.

This on-demand webinar provides an overview of numerous points to consider when deriving a PDE value for an API. These include identifying relevant data, selecting a point of departure, and applying appropriate adjustment factors to derive a PDE value, as well as requirements for documenting the overall process and other factors. Viewers will have a better understanding of why, how, and when to derive PDE values for APIs.

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