UK MHRA Consults On Applying Quality By Design Principles To Monographs
The proposal by the UK regulator builds on a case study which showed that AQbD processes can add value to pharmacopoeial method development.
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Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate.
Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.