in-vitro population bioequivalence [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2019-02-06 07:50 (1993 d 19:17 ago) – Posting: # 19878
Views: 2,271

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According to Draft Guidance on Budesonide, Recommended Sep 2012 notation are as below: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

Complete thread:

UA Flag
Activity
 Admin contact
23,113 posts in 4,858 threads, 1,644 registered users;
50 visitors (0 registered, 50 guests [including 8 identified bots]).
Forum time: 04:08 CEST (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5