Tag Archive | "drug"

Is QbD Still Lost in Translation?

By Paul Thomas, Senior Editor

Quality by Design is at a bit of a sticking point, with guidance documents firmly in place—namely, ICH Q8, Q9, and Q10—but not enough comprehensive (and public) examples of how to implement them. The case studies that have been published are informative but still anecdotal and not always directly relevant to different drugs and different processes.

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