Neera
☆    

India,
2023-05-15 11:24
(780 d 01:14 ago)

Posting: # 23552
Views: 2,122
 

 Gender Effect on Clarithromycin [Regulatives / Guidelines]

Post reply
Hello Everyone,

Hope all good !!!

This is regarding one BE study on Clarithromycin Extended-Release Tablets, USP 500 mg conducted on healthy male subjects for USFDA regulatory.
Received query regarding explanation/scientific justification to support that the BE results from the male-only study can be extrapolated to the entire population consisting of both sexes and that the difference in study population will not affect the BE conclusion.

Searched literatures, but could not get any relevant data to conclude on above query. Your expert opinion is needed. How to handle this query?.

thanks to all.

Have a great day ahead.
 
UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,684 registered users;
42 visitors (0 registered, 42 guests [including 15 identified bots]).
Forum time: 12:39 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

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