We have a compound that is relatively low toxicity. Is there anyway to evaluate the compound to determine if I need an ADE (PDE)?

There are many compounds that are used in pharmaceutical manufacturing that are either low-potency or low-toxicity. These can often include compounds that are considered GRAS (generally regarded as safe). However, it is likely that regulatory agencies will want some assurance that you have evaluated the compound to ensure that you are not getting carryover into the next batch.

In the January 2016 issue of Pharmaceutical Technology (v40n1 pp. 58-62), the authors presented a screening decision chart to assist pharmaceutical manufacturers in this evaluation.

A screenshot of the decision chart is presented below:

If after you go through the decision chart, you still need expert toxicology assistance please contact us.