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Alternatives to animal testing

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,
  • Precision/repeatability/reproducibility,
  • 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.
  • alternative?






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