In vivo ≫ in vitro [Regulatives / Guidelines]

posted by Erkin – Turkey, 2015-09-17 10:39 (3432 d 23:30 ago) – Posting: # 15414
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Hallo Helmut,

Of course, not any in-vitro test simulates as best as the in-vivo does. But I don't understand is: we made a bioequivalence study and we found the products as bioequivalent. After that why we bother about f2 unless sponsor wants to improve their product (and they need to do a new BE study afterall.)

"An ƒ2 value between 50 and 100 suggests that the two dissolution profiles are similar.
When the ƒ2 statistic is not suitable, then the similarity may be compared using model-dependent or model-independent methods e.g. by statistical multivariate comparison of the parameters of the Weibull function or the percentage dissolved at different time points."


I think the key word is "MAY BE COMPARED".

Thank you very much Helmut ;-).

Erkin Alkan

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