in-vitro population bioequivalence [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2019-02-06 06:50  – Posting: # 19878
Views: 961

Hi,

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.

According to Draft Guidance on Budesonide, Recommended Sep 2012 notation are as below:
nT ,nR : Number of canisters or bottles per batch, for T and R products.
lT , lR : Number of batches of T and R products


Data Finalresult;
set AA;
GM_T=Exp(Mean_T);
GM_R=Exp(Mean_R);
meandiff=mean_T - mean_R;
m_T=1;/* no. of stages*/
m_R=1;/* no. of stages*/
n_T=10;/* no. of bottles per batch*/
n_R=10;/* no. of bottles per batch*/
l_T=3;/* no. of batches*/
l_R=3;/* no. of batches*/

your help on this would be greatly appreciated.

Kumar Naidu

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