Three key parameters for your ERA test strategy
von Laus GmbH
Three properties of your API will decide, to what extent you will need to perform Environmental Risk Assessment (ERA):
- octanol-water coefficient (logPOW)
- water solubility
- dissociation constant (pKA)
LAUS can provide these parameters, and together with the Predicted Environmental Concentration (PEC) of the API, you will be able to develop a detailed test strategy and budget. The revised version of the guideline on the ERA of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Rev. 1) requires in phase I the determination of the logPOW, which could trigger a PBT/vPvB assessment. The PEC could trigger phase II testing, where water solubility and pKA are key for the decision which ecotoxicological studies will be required.
Contact us if you are affected. Together we could discuss possibilities…
https://www.laus.group/en/human-medicinal-products/era/
#ERA #LAUSgroup #EnvironmentalRiskAssessment #API #testing
