Can we use the pooled sample results for the calculation of f2?

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Bruce Neagle

Hi Vipul,

I don't have any specific experience on pooled sampling and f2, so I will refer you to the FDA guidance and Health Canada's expert on dissolution.

1. https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf

2. https://www.linkedin.com/in/saeed-qureshi-3664a18/

Lalit Kumar

Usually, we do it by taking n=12 means by taking specific numbers of runs.