HBEL/PDE Loyalty programs
When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern.
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.
Our extensive experience allows us to provide
HBEL/PDE Loyalty programs
SILVER
-
Special price for acquiring more than 1 report
-
One shot payment or monthly fee
-
More than 3.700 available reports (CAS NR:AR) included
-
GOLD
-
Special price for acquiring more than 1 report
-
One shot payment or monthly fee
-
More than 3.700 available reports (CAS NR:AR) included
-
PDE reports renewal during the loyalty program duration
Loyalty PDE programs applies to available PDE reports
Why can we offer PDE Loyalty Programs?
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
Browse our available PDE reports
What needs to be considered?
Health based exposure limits (HBELs) should be established for all APIs of human and veterinary medicinal products manufactured in shared facilities.
- PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.
- The evaluation must be performed by a toxicologist, the expert CV and references shall be included in the report and must be reviewed on a regular basis according to the risk assessment and, after that, either reapproved or modified.
- Each PDE report is prepared for a unique combination of compound (CAS Number) and administration route.
The HBEL should be reassessed periodically when significant data emerges that may affect the HBEL calculation and/or its assumptions.
If we do not have the PDE report for the API you are looking for, request a new report and take advantage of 10% of promotion!
Can't find the report you are looking for?
any new API PDE report 10% off
Promotion available during November & December 2021 for new PDE Reports.
Do You Need Assistance? Contact Our Experts
Just send us your questions & we will give you the help you need.