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� FFA Validated<br />
FFA Validated Release Assay<br />
Drug Substance & Drug Product Release<br />
� Accuracy, precision, LOD, LOQ, specificity, linearity/range,<br />
ruggedness, robustness, system suitability<br />
� Potency is a quantitative measure of infectivity assessed at a<br />
specific time range post-infection<br />
� Precision for FFA is better than for a TCID 50 quantal assay<br />
� Typically 0.1 – 0.15 log 10 FFU<br />
� Typically >0.3 log 10 TCID 50<br />
� Accuracy/specificity requires critical immunoreagents<br />
� Potency testing of trivalent drug product needs to distinguish<br />
between each vaccine component
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