Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]
❝ You mean solutions.
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Edit 2018-10-10 07:14: The draft guidance also says to prove the sameness of API.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]
- Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-08 11:34 [Regulatives / Guidelines]
- BE of parenterals Helmut 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studies nobody 2018-10-09 10:42
- Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies ElMaestro 2018-10-09 11:13
- Enoxaparin sodium injection BA BE studiesvarsha chungde 2018-10-10 07:11