PDE & HBEL reports
Health based exposure limits (HBELS) for a residual active substance must be determinate periodically by each manufacturer for every medicinal or veterinary product and these limits are based on the calculation of the Permitted Daily Exposure (PDE)/ADE.
Azierta is a European scientific reference company in the development of PDE/ADE reports, we have:
More than 3700 PDE reports
already available.
Evaluated more than
2500 compounds
More than 190 customers worldwide that have trusted us
Presence in more
than 50 countries
Why Azierta PDE reports?
- Are prepared and reviewed by highly qualified toxicologists.
- Include a robust assessment based in scientific information and expert criteria of the evaluator.
- Provide comprehensive discussion for the derivation of the PDE value.
- Evidence precise and reliable value as a result.
- Our highly specialized multidisciplinary team prepares PDE/ADE (Permitted Daily Exposure) reports for any API according to the EMA directive (EMA/CHMP/CVMP/SWP/169430/2012) for the pharmaceutical and veterinary industry.
At Azierta, we have a specialized area in Toxicological support composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT.
Do you want to request a PDE or OEL report?
Contact with our experts
You can request some PDE or OEL reports from our catalogue or from every API that you need.