Drug developmentDetermination of OEL and PDE
TKT has vast experience in risk assessment, including assessment of Permitted Daily Exposure (PDE) and industrial hygiene risk assessment and the determination of occupational exposure limits (OEL/OEB). All to ensure the safety for patients and drug manufacturing workers as well as the quality of drug products.
Numerous reports have been delivered to national and international customers. For any PDE or OEL assessment requested by the customer, TKT ensures a scientifically based report with high quality for the manufacturing of an API or drug product.
Additionally, TKT conducts risk assessment on compounds with limited toxicological data (process intermediates and candidate drugs under development) on a regular basis.
The PDEs are prepared and reported in compliance with the “European Medicine Agency’s (EMA) guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.
OELs are derived according to recommendations by the ECHA/RAC-SCOEL Joint Task Force of the European Commission “Guidance for preparing a scientific report for health-based exposure limits at the workplace”.
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