Use of PBPK modeling for estimating risk for vulverable populations
In determining the safety of chemical compounds for humans, regulating government agencies must take into account the interspecies variability given that the studies to develop estimates of safety are based on animals. Typically, a factor of 10 is used for interspecies variability (that is the level deemed safe in animals is lowered 10 times for humans). Additionally, regulating agencies adjust for intraspecies variability by a factor of 10 and there may be other adjustments for vulnerable populations like children.
ScitoVation PBPK modeling in risk assessment to discover how:
- PBPK models can be used for addressing interspecies and intraspecies variability
- The use of in vitro to in vivo extrapolation (IVIVE) to parameterize PBPK models
- A specific example of how we used a PBPK model for pyrethroids (a chemical class of widely used insecticides) to show that no adjustment is needed for children)
- The model was submitted to EPA and is currently under evaluation
- Lessons learned from the submission to EPA will be shared