Bioequivalence and Bioavailability Forum

Hi John,

❝ 1) Where did you get the IV or IR data to generate the impulse function for convolution/deconvolution? Was the data originated from the same 2 studies or from another source?

The data was originated from the same two studies not from any other source.

❝ Well your results showed that internal validation was a failure due to the poor predictability of the model so you don't have an IVIVC.

Can I upload my data, will you please take a look upon it?

❝ You can generate a 2 formulation IVIVC but it will be of limited use when compared to a 3 formulation IVIVC. Particularly if you want to use it for setting dissolution specification. You can't propse +/- range for your in-vitro release spec because you can't justify or support your proposal for the +ve range if your IVIVC only shows correlation to support the -ve range of the spec, or vice versa.

Thank you very much for this clarification.

Thanks & Regards
Anu Jaswal