Bioequivalence and Bioavailability Forum • Sub-investigators on 1572 form

Sub-investigators on 1572 form [Regulatives / Guidelines]

posted by Ohlbe – France, 2011-03-24 01:20 (5557 d 20:09 ago) – Posting: # 6799
Views: 3,958

Dear Johanne,

First of all the 1572 form is only needed if the study is run under an IND. This can be the case in a BA or in a bridge BE, but it is very unusual in a BE for generic drugs.

Did you look at this Q&A ? Particularly points 31 and 7 ?

Regards
Ohlbe

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Regards
Ohlbe

Complete thread:

Sub-investigators on 1572 form jlanteigne 2011-03-23 23:14 [Regulatives / Guidelines]
- Sub-investigators on 1572 formOhlbe 2011-03-24 00:20
  - Sub-investigators on 1572 form and financial discosure jlanteigne 2011-03-24 15:34
    - Sub-investigators on 1572 form and financial discosure Ohlbe 2011-03-24 18:56
    - Sub-investigators on 1572 form and financial discosure aracine 2011-03-25 20:04