Number of sets selection in In-Vitro Kinetic and Equilibrium Binding study [Regulatives / Guidelines]

posted by Sivakrishna – India, 2021-06-10 08:12 (11 d 01:46 ago) – Posting: # 22401
Views: 173

Dear All,

Good Morning!

Please let me guide, how to select the number of sets in In-Vitro Kinetic and Equilibrium Binding study. As per the Sevelamer Hydrochloride OGD, Each binding study should be repeated at least 12 times.

1. Is there any procedure to find the number of sets (sample size) required for equilibrium
2. The Slope and Intercept was calculated using the Linear Regression and the obtained
intercept was found to be in negative for some sets. Is it acceptable by regulatory,
Specially USFDA?

your quick response is appreciable.

Thanks in Advance

Thanks and Regards

G. Siva Krishna Teja,

Complete thread:

 Admin contact
21,530 posts in 4,499 threads, 1,524 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Monday 09:59 CEST (Europe/Vienna)

Young man, in mathematics you don’t understand things.
You just get used to them.    John von Neumann

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