How does Affygility Solutions determine the OEL and/or ADE?

In the majority of cases, the occupational toxicology professionals at Affygility Solutions calculate the OEL and/or ADE by using the adjustment factor and modifying factor method, which is the most commonly used method for determining OELs and ADEs in the pharmaceutical industry. However, in some rare cases, if benchmark response data is available, we would use that information.

We begin this process by collecting available information from both public sources and proprietary databases. After a thorough review of the available data by expert toxicologists, we select a toxicological point of departure (POD) based on numerous factors such as relevance to human occupational exposure, data quality, study duration, etc. In total, there are at least sixteen factors we consider, prior to selecting the POD. Once we have determined the POD, we then determine the uncertainty factors and modifying factors to be used and the OEL is then calculated.

The specific uncertainty factors and modifying factors used depend upon the completeness of the data set, whether we are considering animal or human data, whether the data is acute or chronic, and many other factors. If available, absorption and bioavailability information is also considered.