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Dear Sir For drug substance which formula we need to use for fixing the limits.Suppos ethe DS maximum daily dose is 200 than how to we calculate the limit. 0.10% or 1 mg whichveer is lower as per ICH Q3. But if we take the formula 100/MDD = 100/200 =0.5. Please clarify?

Author: vbreddy123
Posted: 12/04/2015