Module 3 2019

Drug Substance Assay Accuracy

•

“Expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference

Accuracy normally needs to be inferred from other tests • There is normally no absolute method (titration may be the closest) • Infer from:

value and the value found… sometimes termed trueness”

• Recovery data, absence of bias as demonstrated by linearity and mass balance if possible

The Organisation for Professionals in Regulatory Affairs