In accordance with the 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' (EMA/CHMP/ CVMP/ SWP/169430/2012) the determination of health based exposure limits for a residual active substance is based on the calculation of the Permitted Daily Exposure (PDE)/ADE.
Azierta PDE/ADE Reports
Azierta is an European scientific reference company in developing PDE/ADE reports:
- PDE/ADE report for any API.
- Scientific expert team.
- More than 1800 PDE/ADE report catalogue.
- Flexible pricing. If you need a large amount of reports we can mutually agree a special price.
PDEs/ADEs are based on the toxicological properties and pharmacology of the specific active pharmaceutical ingredient (API).
Determination of a PDE/ADE involves:
- Hazard identification by reviewing all relevant data.
- Identification of 'critical effects'.
- Determination of the no-observed-adverse-effect level (NOAEL) of the findings that are considered to be critical effects.
- Use of several adjustment factors to account for various uncertainties.