Bioequivalence and Bioavailability Forum • one drug substance, 2 brands with different indications

one drug substance, 2 brands with different indications [Regulatives / Guidelines]

posted by Shuanghe – Spain, 2011-03-18 17:04 (5582 d 23:13 ago) – Posting: # 6776
Views: 3,693

Thanks Jaime!

❝ I would say, you are right - and the business guy wrong.

yeah...

But I need hard evidence to convince them. It would be wonderful if there's guideline or some regulation rules to follow. I couldn't find anything useful in EMA website but that may just due to my lack of knowledge in regulatory process. Usually I'd :google:

but this time, well, embarrassingly, I don't even have a clue which key words to use. :confused:

Any further help?
Shuanghe

—
All the best,
Shuanghe

Complete thread:

one drug substance, 2 brands with different indications Shuanghe 2011-03-18 11:59
- one drug substance, 2 brands with different indications Jaime_R 2011-03-18 12:59
  - one drug substance, 2 brands with different indicationsShuanghe 2011-03-18 16:04
    - one drug substance, 2 brands with different indications Helmut 2011-03-18 21:25
      - one drug substance, 2 brands with different indications Shuanghe 2011-03-21 10:10