Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE).
The performance of the equivalence test in the context of analytical method transfers was investigated by means of a simulation study. An ISPE design proposal and typical error contributions for pharmaceutical routine control have been used for the testing of accuracy. Acceptable results (probability of a correct decision) have been obtained here. For total variations above 0.4% R.S.D. the basic design was not sufficient. An overview for the number of additional series needed corresponding to higher variations has been developed based on further simulations. An alternative approach may be the choice of wider acceptance criteria, which was also evaluated.
Schepers
U
U
Institute of Pharmaceutical Chemistry, TU Braunschweig, Germany.
Wätzig
H
H
D002626:Chemistry, Pharmaceutical; D012952:Societies; D012984:Software