Bioequivalence and Bioavailability Forum • C of A

C of A [GxP / QC / QA]

posted by M.Vasu – India, 2011-02-17 05:24 (5600 d 22:23 ago) – Posting: # 6638
Views: 9,011

Hi Dr_Dan,

I do agree, this is a registrated and marketed product (reference). As per the IEC approved protocol it was stated that the study will conduct in complince with the GCP. However, i feel as per GCP sec 8.2.16 (C of A of IP's shipped) sponsor has to file C of A.

Regards,
VM

Complete thread:

C of A M.Vasu 2011-02-10 14:14
- C of A Ohlbe 2011-02-10 16:01
  - C of A M.Vasu 2011-02-10 16:18
    - C of A Ohlbe 2011-02-10 22:31
      - C of A Dr_Dan 2011-02-16 11:00
        
        C of AM.Vasu 2011-02-17 04:24
        
        C of A Dr_Dan 2011-02-17 10:26
        
        C of A Ohlbe 2011-02-21 19:09
        
        C of A Dr_Dan 2011-02-22 09:42