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GSTATS ☆  India, 2011-06-07 20:45 (5500 d 00:13 ago) Posting: # 7095 Views: 4,649 |
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Hello Everyone, I was going through the FDA guidelines on establishing In-vitro Bioequivalence as it was suggested for Sevelamer. It has been mentioned to calculate two values, K1 and K2, using regression. And then bioequivalence shall be concluded on the basis of 90% CI for K2 for Equilibrium binding study. So, two questions popped up in my mind: 1) How many times an experiment setup should be repeated or in other words, what should be the sample size? 2) Which method should be used for the calculation of 90% CI? Thanks, GSTATS www.gstatsolutions.com Copypasted below from a deleted follow-up post; no necessity to reply to yourself within 24 hours – edit instead. See the Policy FAQ #3. [Helmut] In an interim guidance for CHOLESTYRAMINE POWDER, FDA has quoted "The experiment should be repeated six times under the conditions described above to obtain six sets of data." But in that case, my concern is very small sample size to say anything or to apply any method to estimate 90% Confidence Intervals. — Let Noble Thoughts come from Every Side: RIG VEDA |
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Tushar.g ☆ India, 2012-04-23 09:49 (5179 d 11:10 ago) @ GSTATS Posting: # 8455 Views: 3,395 |
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Hello GSTAT and Hi all, Even I am facing some queries related to sevelamer IN VITRO Bio-Equivalence. As per the current FDA guidelines of Sevelamer Hydrochloride, we have conducted the equilibrium binding study for test and reference at 8 different levels of concentrations of phosphate. Then this binding study is repeated over 12 times. Now for further data calculation, I have considered these 8 levels of concentration and then calculated K1 and K2 for each study. Same way for 12 repeats So eventually I got 12 values of K1 and K2 for test and reference individually. These K1 and K2 are calculated using Linear Regression in which some of K1 and K2 are negative. Do negative values exist for K1 and K2? Am I going on a right path? Which method should I use to calculate 90% CI for ratio of K2?  Thanks in advance. Regards, Tushar |
Ing. Helmut Schütz