Publications by authors named "Tanja Bernier"
Article Synopsis
- Permitted Daily Exposure Limits (PDEs) for Active Pharmaceutical Ingredients (APIs) are crucial for managing cross-contamination in shared manufacturing facilities, but companies must set their own limits due to the absence of official lists.
- Despite the existence of general guidelines, variations in PDE settings among companies are acceptable within a defined range.
- A study comparing PDEs for five marketed APIs demonstrated that the variations are generally minor (under 10-fold), with notable differences primarily for morphine, highlighting factors such as data availability and company policies that influence these limits.
In the pharmaceutical industry, cleaning criteria are required for multipurpose manufacturing facilities. These Health Based Exposure Limits (HBELs), also called permitted daily exposures (PDEs) values, are derived from toxicological and pharmacological evaluation of the active pharmaceutical ingredients (APIs). The purpose of this publication is to show an example of how authors from different companies evaluate a generic drug, paracetamol, and discuss different approaches and relevance of the nonclinical studies for deriving PDEs.
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