In the context of setting health-based exposure limits for the prevention of cross-contamination of different medicinal products, the term permitted daily exposure (PDE) was first defined in the European Medicines Agency (EMA) Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (hereafter referred to as the “HBEL guideline”) in December 2012 (draft version).
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