Here at Affygility Solutions, we often get asked to provide a comprehensive list of all permitted daily exposure (PDE), also known as acceptable daily exposure (ADE), values for active pharmaceutical ingredients (API)s. While I’m sure that there’s someone that could come up with a spreadsheet listing hundreds or thousands of different PDE values, such a listing would lack all scientific credibility and would not pass regulatory authority scrutiny. As indicated in the EMA’s “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” all monographs must “Following an expert review, the company should provide a discussion with respect to the critical endpoints of concern and their rationale for the choice of endpoints and dose that is to be used in the derivation of the PDE.” This means that all monographs must be well documented and include a listing of the scientific references used to determine the permitted daily exposure value.
The toxicology and pharmaceutical industry experts at Affygility Solutions have a comprehensive online catalog of OEL/ADE (PDE) monographs, which lists over 1900 generic APIs, or APIs in which their patents will expire in the next several years. This listing of permitted daily exposure (aka ADE) monographs is constantly growing. To obtain a RSS feed of our monograph listing, go to https://affygility.com/oel/feed.html
All of the monographs listed in our catalog offer the following benefits:
- Save money and time with instant download of reports available 24/7
- Ensure compliance with EMA, PIC/s, ANVISA, and WHO requirements with FREE periodic updates that are automatically distributed
- Achieve cost-effective risk-management and numbers you can trust with CPhI award winning PDE reports that are prepared by experienced/certified (ERT and DABT) toxicologists with real pharmaceutical industry experience
- Save money and demonstrate compliance to auditor questions through FREE online/offline technical support
Need a permitted daily exposure value for an API that is not currently listed in our catalog? Need a custom permitted daily exposure value monograph for a proprietary compound? Please contact the toxicology experts at Affygility Solutions.