Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the PQRI L&E Working Group, EPR outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
United States Diane Paskiet Hannah Balfour Product Quality Research Institute International Council For Harmonisation Drug Administration
Source: europeanpharmaceuticalreview.com