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Registerin-vitro population bioequivalence [Regulatives / Guidelines]
Hi kumarnaidu,
» We have conducted the Beclomethasone in-vitro population bioequivalence study for spray pattern test. Ten units for three batch of test and reference products were used for beginning life stage only.
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» In this experiment, three reading were measured each canisters of beginning life stage only (m=1). My question is such case, n: Number of canisters or bottles per batch, for T and R products would be 10 or 30.
n is the number of units per batch; in this case it sounds like you have n=10. This is usually not enough to secure a reasonable chance to show BE for nasal products and inhaled products (regardless of pMDI, DPI or nebs).
» We have conducted the Beclomethasone in-vitro population bioequivalence study for spray pattern test. Ten units for three batch of test and reference products were used for beginning life stage only.
»
» In this experiment, three reading were measured each canisters of beginning life stage only (m=1). My question is such case, n: Number of canisters or bottles per batch, for T and R products would be 10 or 30.
n is the number of units per batch; in this case it sounds like you have n=10. This is usually not enough to secure a reasonable chance to show BE for nasal products and inhaled products (regardless of pMDI, DPI or nebs).
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I could be wrong, but...
Best regards,
ElMaestro
No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
I could be wrong, but...
Best regards,
ElMaestro
No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
Complete thread:
- in-vitro population bioequivalence kumarnaidu 2019-02-06 06:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- in-vitro population bioequivalenceElMaestro 2019-02-06 08:55
Ing. Helmut Schütz