We have an early stage compound; can we get an OEL Fastrac monograph developed for the compound?
| While Affygility Solutions can develop an OEL Fastrac monograph for almost any active pharmaceutical ingredient (API); for early stage APIs, it is not always practical to attempt the development of an occupational exposure limit. This is because what is unknown about an early stage API overwhelms what is known. Thus the uncertainty factors become large and can result in an unreasonably low OEL. In these cases, Affygility Solutions recommends that a simple occupational health categorization (OHC) report (without a numerical OEL) be prepared. Here at Affygility Solutions, we call these reports an Occupational Health Categorization reports. Because data on the specific API may be extremely limited, the occupational toxicology experts at Affygility Solutions may have to use structure activity relationship information, as well as any early study information that you may have in your possession. Therefore, it is likely that your company will need to establish a non-disclosure agreement with Affygility Solutions. To initiate the process of the occupational toxicology experts creating a classification report, please contact us. |