On June 1, 2015, the European Medicines Agency's Guideline on setting health-based exposure limits (HBEL) for use in risk identification in the manufacture of different medicinal products in shared facilities came into effect. In this guideline there is the requirement to perform permitted daily exposure (PDE*) calculations.
The general process for performing these calculations is as follows:
The calculation for acceptable daily exposure (ADE) (mg/day) = (NOAEL x BW) / (UFc x MF x PK)
It should be noted, that while the equation for calculating the ADE seems simple, the determination of the appropriate PoD and the selection of the uncertainty factors requires an expert toxicologist.
Here at Affygility Solutions, we have a large catalog of occupational exposure limit monographs for generic pharmaceutical compounds. Many of these monographs also contain the ADE value and the necessary documentation to comply with the EMA Guideline. If you have a proprietary compound, we can also develop an OEL monograph with the ADE value.
Please contact us for additional information.
All monographs are prepared by industry experts with advance degrees, decades of industry experience, and professional certifications.