Discriminatory power of the different requirements for uniformity of dosage units in the European pharmacopoeia.
The discriminatory power of the new and the old requirements are compared on a mathematical basis and by the simulation of data. The probability of passing the requirements of the test for uniformity of dosage units versus the tests for uniformity of content and uniformity of mass are compared by the simulation of different batches. These batches are characterised by a true content and true standard deviation under the prerequisite of normal distribution. Furthermore, a mathematical evaluation of the newly introduced acceptance value AV is presented.
Limberg
J
J
Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany.
Savsek
M
M
D003198:Computer Simulation; D004304:Dosage Forms / Q000592:standards*; D004348:Drug Labeling; D004355:Drug Stability; D005060:Europe; D008962:Models, Theoretical; D016011:Normal Distribution; D010602:Pharmacopoeias as Topic; D011336:Probability; D011786:Quality Control; D012015:Reference Standards; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
D004304:Dosage Forms