05
Feb
Researcher adding liquid from test tube with fire symbol, warning sign, danger

The “Unwelcome Guest” Spares Metformin

Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here).  Great news!  NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen.  The nitrosamines, including NDMA, […]

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30
Jul
Girlfriends using a map on station

ICH Q12 – Ready or Not, Here it Comes!

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum).  This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and […]

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