Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime.

A PDE report usually includes calculations and considerations related to the highest acceptable intake of a potentially harmful substance over the course of a day. These calculations are often based on toxicological data and are used to ensure safety in a variety of contexts, including occupational health, pharmaceuticals, and environmental health.

Just like PDE, the ADI (admitted daily intake) is calculated based on detailed scientific evaluation which includes studies on animals to identify possible health effects, the dose at which they occur, and the identification of a safe level of exposure for humans. The ADI includes a wide safety margin to ensure it is protective for all human populations including the most vulnerable, such as children and those with illnesses.

They are crucial for determining safe levels of potential impurities in drug substances and products. During drug manufacturing, tiny amounts of impurities (which could be residual solvents, catalysts, or degradants) can be introduced into the final product. PDE/ADI values help establish acceptable levels for these impurities, ensuring that if they are present, they’re at levels that are not expected to cause harm.

We are more than happy to provide the PDE/ADI assessment report you are interested in. Please contact us using the contact form (link) or send your request via e-mail: contact@toxopharmonia.com