Bioequivalence and Bioavailability Forum

Hi Mahesh,

❝ As per SPC “No accumulation is observed after repeated administration of up to 2000mg of metformin as prolonged release tablets then why applicant performed multiple dose study?

See this thread. We don’t know when the studies supporting this application were performed. According to the NfG of 1999 multiple dose was mandatory – unless you convinced regulators of the opposite (scientific advice, etc.). The current GL – which allows waiving the multiple dose study under certain conditions – came into effect on 1 July 2015.
Low accumulation indeed: “Out of 66 [33 Subjects × 2 periods] possible values, only 27 values were plausible, rest were BLQ and therefore C_τ,ss was not acceptable and hence, not considered for bioequivalence equation.”

BTW, as usual in Indian studies the – irrelevant – “post hoc power” is wrong. Given these numbers in the PAR the assessors’ knowledge appears in a bad light.