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



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?