When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern.
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.
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
12 Months
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
36 Months
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
Popular
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 2500compounds
More than 190 customers worldwide that have trusted us