Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by nobody – 2018-10-09 10:42 (1082 d 22:18 ago) – Posting: # 19418
Views: 2,588

» As per guideline we need not to perform any Bioequivalence studies for Injectables.

That's simply not true at all.

There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun!

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
21,700 posts in 4,538 threads, 1,542 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Sunday 09:01 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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