Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]
❝ 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!
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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- 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 studiesnobody 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 studies varsha chungde 2018-10-10 07:11