BE of parenterals [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-10-08 11:53 (784 d 00:50 ago) – Posting: # 19416
Views: 2,348

Hi Varsha,

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

It’s not that simple. See e.g., the EMA’s GL page 23.

» But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies.

That’s not the point. See the FDA’s guidance for conditions whether the in vivo PD (!) study can be waived.

» Does the guideline differs for a biologically derived product?

Differ to what? To get an idea, see the EMA’s guidelines on biosimilars.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,223 posts in 4,427 threads, 1,481 registered users;
online 20 (1 registered, 19 guests [including 12 identified bots]).
Forum time: Monday 11:43 CET (Europe/Vienna)

It’s difficult to work in a group
when you are omnipotent.    John de Lancie (as Q)

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