Eur. 2.9.40) for the content UDU, which is based on either 10 or 30 dosage units. The PhRMA CMC SET proposed an alternative to the ICH test to address the issue of developing acceptance criteria for ...

She holds a Bachelor of Science in Finance degree from Bridgewater State University and helps develop content strategies. FreshSplash / Getty Images A means test is a formula that uses someone's ...

Sample content uniformity acceptance limit tables Tables assume that the target (i.e., the average of potency specification) is 100% and that the sampling plan is to test one dosage unit from each of ...