One approach I have seen was to use a correlation between OEL and data available as the API is developed. In the order of least-to-most reliable reference point the OEL could be calculated from:
1. NOAEL (Animal) (pre-Phase I preliminary tox data)
2. NOAEL (Human) (Phase I data)
3. LOAEL (Animal) (pre-Phase II 6-mo tox data)
4. LOAEL (Human) (Phase I and/or II data)
5. TDmin (Human) (Phase III data)
These values would be adjusted by appropriate factors (Body Weight, species-to-species Uncertainty Factors, adjustments for pharmacokinetics, Breathing Rate, bioavailability).
Not all data is available at all stages of development. There is nothing special about HP-APIs except that the exposure numbers get really small. Below 1 =ECg/m^3 all work needs to be done in isolators (lab scale) or in flexible containment (pilot plant/production scale).
As usually, engineering controls are established first to get the exposure below OEL and PPE is added on top to protect workers in case of a breach of containment.
Slawomir Janicki, Ph.D.
I have a colleague who is working on a consulting project and he is looking for Occupational Exposure Limits for pharmaceuticals. His request is given below. Any help is appreciated.
Any idea where I can get a list of OELs for pharmaceuticals? I am specifically interested in the so-called high-potency active ingredients (HPAPI) that are typically Safebridge category 3 and 4. Most of the OEL lists out there have all manner of industrial chemicals, and I'm hoping that you can help me find a more focused list.
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