Bioequivalence and Bioavailability Forum • Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph

Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph [Regulatives / Guidelines]

posted by dshah – India, 2022-07-08 12:23 (1102 d 21:18 ago) – Posting: # 23115
Views: 4,408

Dear Osama!

❝ But let us return to the main topic, should the regulatory authorities refuse the submission and acceptance of BE studies that have been performed in a CRO belonging to the sponsor? are there any references? or are there other opinions other than that?

Unless study trend/result is too much doubtful, regulatory bodies generally does not refuse for submission and acceptance. I believe as a sponsor, the submission of all the studies including failed one is important during such time as it gives impression that sponsor has appropriate formulation which are BE to RLD.

Regards,
Divyen

Complete thread:

Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-07 10:37 [Regulatives / Guidelines]
- Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Ohlbe 2022-07-07 10:55
  - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph dshah 2022-07-07 18:52
    - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-07 20:48
      - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Phdshah 2022-07-08 10:23
- Conflicts of interest (COI) ElMaestro 2022-07-08 13:18
  - Off topic Helmut 2022-07-08 16:29
    - Off topic ElMaestro 2022-07-08 16:54
      - Off topic Helmut 2022-07-08 20:41
        
        CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-08 22:18
        
        CRO belong to the pharmaceutical Company (CRO b2Ph ElMaestro 2022-07-09 08:51
        
        CRO subsidiary of pharmaceutical company Helmut 2022-07-09 19:21