in-vitro population bioequivalence [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-02-06 08:55 (660 d 21:11 ago) – Posting: # 19879
Views: 1,066

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.
»
» 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).

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.

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