How to get from a ‘promising’ alternative to a Ph. Eur. Alternative?
For any new alternative method need to see:
- •Proof of concept;
− Evidence that parameter measured has some relevance to the potency/safetyof the medicinal product,
− Consistencyof that parameter with a lot that has been shown to be efficacious in clinical trial (GMP),
- Assay specificity,
- Dose response in appropriate range,
- Ability to detect sub-standard batch,
- Correlation with former (in vivo) test ???
- Can be problematic because of poor quality of former test,
- While desirable it is not obligatory if sufficient alternative evidence of suitability is available.