Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 07:11 (749 d 03:19 ago) – Posting: # 19424
Views: 2,151

» You mean solutions. :-D

Yes i mean injectable aqueous solution. As enoxaparin injection is API in aqueous solution. But enoxaparin being a biotech product, i just needed an clarification. Do we need to prove our AP to be similar or good enough to waive the BE studies.


Edit 2018-10-10 07:14: The draft guidance also says to prove the sameness of API. [Varsha]


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Merged with a later (deleted) post. You can edit your post within 24 hours. [Helmut]

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: Wednesday 09:31 CET (Europe/Vienna)

Actually, science starts to become interesting
only where it ends.    Justus von Liebig

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