kumarnaidu
★    

Mumbai, India,
2019-02-06 06:50

Posting: # 19878
Views: 524
 

 in-vitro population bioequivalence [Regulatives / Guidelines]

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According to Draft Guidance on Budesonide, Recommended Sep 2012 notation are as below: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
ElMaestro
★★★

Belgium?,
2019-02-06 08:55

@ kumarnaidu
Posting: # 19879
Views: 436
 

 in-vitro population bioequivalence

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
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