kumarnaidu
★

Mumbai, India,
2019-02-06 07:50
(2009 d 21:02 ago)

Posting: # 19878
Views: 2,319

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According to Draft Guidance on Budesonide, Recommended Sep 2012 notation are as below: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

Denmark,
2019-02-06 09:55
(2009 d 18:57 ago)

@ kumarnaidu
Posting: # 19879
Views: 1,941

## 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).

Pass or fail!
ElMaestro