English to Russian Medical Medical: Pharmaceuticals

A change of the acceptance criterion for the QC dissolution test for the simeprevir capsules from Q=80% at 30 minutes to Q=80% at 45 minutes is proposed because the Q=80% at 30 minutes criterion was found to be too tight to ensure a stable commercial supply as indicated by the large number of stage 1 *failures* caused by the high variability in dissolution results and the overly discriminating nature of the QC dissolution method.

The Applicant proposes a change in the dissolution acceptance criterion from Q=80% at 30 minutes to Q=80% at 45 minutes in order to reduce the variability of the results, the number of stage 1 *failures*, and the potential risk of batch rejection.