Permitted Daily Exposure/Admitted Daily Exposure Limits for any substance.
If different pharmaceutical products are manufactured in the same facility, there’s always a risk of cross-contamination due to residuals of pharmaceutical ingredients, by-products, or detergents. To reduce the danger for people using your final product, it’s essential to know how many residues of a certain substance could technically still be in the used equipment without causing any harm.
The Permitted Daily Exposure (PDE) or Admitted Daily Exposure (ADE) marks the dose of a specific substance that’s unlikely to cause an adverse effect if the same person is exposed to this amount – or less – every day, for a lifetime.
Consequently, it is important to know this limit for every substance that could technically be found in your final product, and to make sure it’s at most contained in its daily dose. The PDE can then be used to calculate other necessary limit values, and to determine which equipment – or even facility – should be used dedicated to specific products.
Since it is a crucial value, the exposure limit is based on calculations determined by the official European Medicine Agency guideline (EMA/CHMP/ CVMP/ SWP/169430/2012). As requested by the guideline, our determination of the PDE involves:
- Hazard identification by reviewing all relevant data, such as medicinal and toxicological data bases and studies
- Identification of 'critical effects', i.e. the most harmful effects a substance can have
- Determination of the no-observed-adverse-effect level (NOAEL) of the findings that are considered to be critical effects
- Careful use of several adjustment factors to account for various uncertainties, such as non-ideal conditions in the consulted studies.
Your PDE reports are prepared by a multidisciplinary team consisting of members certified by AETOX, EUROTOX and ERT. These experts are following the detailed requirements asked for by authorities so you can be sure to get high-quality PDE reports.
We provide PDE reports for any active pharmaceutical ingredient (API). Each report is based on the toxicological properties and pharmacology of the specific API. A large pool of over 1800 existing reports is already available to choose from, but we’re more than happy to create a new one to add to the list for an additional API, if necessary.