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RegisterStatistical comparison of dissolution profiles - variable nr of units [Dissolution / BCS / IVIVC]
Dear BEBAC team,
What is your position on comparing dissolution profiles with different number of units? As far as I know, guidelines state one should use 12 units of each batch. However, sometimes and for QC reasons, we have 18 units of one batch and 12 units of another.
I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?
Thanks in advance,
Marta
What is your position on comparing dissolution profiles with different number of units? As far as I know, guidelines state one should use 12 units of each batch. However, sometimes and for QC reasons, we have 18 units of one batch and 12 units of another.
I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?
Thanks in advance,
Marta
—
Regards,
MSimoes
Regards,
MSimoes
Complete thread:
- Statistical comparison of dissolution profiles - variable nr of unitsMSimoes 2019-07-17 18:13 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Statistical comparison of dissolution profiles - variable nr of units ElMaestro 2019-07-17 21:02
- Statistical comparison of dissolution profiles - variable nr of units MSimoes 2019-07-18 10:22
- EU: No Mahalanobis Helmut 2019-07-18 13:06
- Statistical comparison of dissolution profiles - variable nr of units ElMaestro 2019-07-17 21:02
Ing. Helmut Schütz