Objective: Pain-Relief Product–Development and Validation for Two Formulation Methods—one for a Low Dose and Higher Dose Combination.
The Challenge: Method used for stability and release was not qualified; the method was 70 minutes long. Work was performed in-house and with another CRO; Method did not meet ICH LOQ guidelines.
The MRIGlobal Solution: We de-convoluted the method into two separate methods that are compliant and shorter.
Outcome: The customer has a fully compliant method that meets ICH guidelines and completes analysis in half the time of the original method.