Bioequivalence and Bioavailability Forum • in-vitro population bioequivalence

kumarnaidu
Regular

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

Posting: # 19878
Views: 218

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According to Draft Guidance on Budesonide, Recommended Sep 2012 notation are as below: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

Denmark,
2019-02-06 08:55

@ kumarnaidu
Posting: # 19879
Views: 178

in-vitro population bioequivalence

Post reply

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).

—

 if (3) 4 



x=c("Foo", "Bar") 

b=data.frame(x) 

typeof(b[,1]) ##aha, integer?

b[,1]+1 ##then let me add 1

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Bioequivalence and Bioavailability Forum 06:56 CET

in-vitro population bioequivalence [Regulatives / Guidelines]

in-vitro population bioequivalence