A multidisciplinary team of industrial hygienists, exposure scientists, and toxicologists at ToxStrategies has experience in assignment of occupational exposure bands (OEBs) and development of occupational exposure limits (OELs). OEBs/OELs can be derived based upon client-tailored frameworks or according to contemporary best practices in accordance with authoritative recommendations. ToxStrategies scientists are well-versed in deriving exposure limits for modalities including:
- Small molecules
- Peptides
- Monoclonal antibodies
- Proteins/enzymes
In addition to OEBs and OELs, ToxStrategies staff also derive permitted daily exposures (PDEs)/acceptable daily intakes (ADIs) to support manufacturing of active pharmaceutical ingredients (APIs).
ToxStrategies scientists leverage available clinical, in vivo, and new approach methods (NAMs) data to develop exposure limits for key exposure routes for populations of interest, including workers, patients, and other susceptible populations. For compounds lacking data, incorporation of read-across techniques and quantitative structure activity relationship (QSAR) models are used to inform potential API hazards. An overall weight of evidence is considered to identify the most relevant point(s) of departure (POD) and inform selection of assessment factors in derivation of the exposure limits. Where appropriate, benchmark dose modeling may also be used to refine PODs.
Once an exposure band or limit has been derived, ToxStrategies’ team of industrial hygienists and exposure scientists can support implementation of qualitative risk characterization and control banding measures to ensure employee exposures are effectively controlled. When needed, sampling plans or methods may also be developed to verify the adequacy of control measures. For more information, please see our industrial hygiene service offerings.
For more information regarding pharmaceutical services and capabilities, please visit our service page.