f2 Calculation For Rapidly Dissolving FPPs [Dissolution / BCS / IVIVC]
Dear All,
Even though I have not come across this scenario in practice, I am imagining a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?
I am aware, the requirements are different for different NRAs (USFDA, EMEA, WHO, etc). I will appreciate if these are taken into account when answering this question.
Regards,
Even though I have not come across this scenario in practice, I am imagining a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?
I am aware, the requirements are different for different NRAs (USFDA, EMEA, WHO, etc). I will appreciate if these are taken into account when answering this question.
Regards,
—
Scopy
Scopy
Complete thread:
- f2 Calculation For Rapidly Dissolving FPPsObinoscopy 2018-04-22 15:11 [Dissolution / BCS / IVIVC]
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- Sample after >85% release Helmut 2018-04-29 13:53
- Sample after >85% release Obinoscopy 2018-04-28 20:30
- Sample after >85% release wienui 2018-04-27 03:23
- Sample after >85% release Obinoscopy 2018-04-27 02:51
- Sample after >85% release wienui 2018-04-25 18:46
- Sample after >85% release Obinoscopy 2018-04-24 13:00
- Sample after >85% release wienui 2018-04-23 03:32
- FPP Ohlbe 2018-04-23 11:10
- Sample after >85% release Helmut 2018-04-22 16:56