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 1530 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 from a large, searchable listing of over 1530 generic compounds. Available 24/7 for easy credit card purchase.
- Achieve cost-effective risk-management by having OEL/ADE/PDE values that you can trust and that are prepared by expert toxicologists that have decades of industry experience and are board-certified. Our monographs are widely accepted by the regulatory authorities throughout the world.
- Comply with EMA requirements by listing the technical references that are traceable back to the scientific sources.
- Ensure compliance with the EMA and PIC/s health-based exposure limit requirements (EMA/CHMP/CVMP/SWP/169430/2012) with FREE periodic updates that are automatically distributed.
- Save cost 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.