Module 3 Presentations

07/05/2024

Drug Substance Assay Linearity

r = 0.9999

The Organisation for Professionals in Regulatory Affairs

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Drug Substance Assay Accuracy

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

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

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

14

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