Bioequivalence and Bioavailability Forum • exclusion of subject due to vomiting

exclusion of subject due to vomiting [Regulatives / Guidelines]

posted by ratnakar1811 – India, 2011-06-15 08:49 (5494 d 22:42 ago) – Posting: # 7128
Views: 11,525

Dear HS and Ohlbe,
Thanks for prompt reply;

❝ In my studies for EMA I’m using FDA’s rules (IR: 2× t_max,ref, MR: τ) and never had any problems.

Were there any queries from any of the regulatory authority from EU, after recent guideline has been implemented, as one of our sponsors is not very satisfied with the approach and asking to withdraw a subject from the study during clinical phase only if there is any vomiting during clinical phase?

Best Regards,

Ratnakar

Complete thread:

exclusion of subject due to vomiting ratnakar1811 2011-06-11 08:06
- exclusion of subject due to vomiting Ohlbe 2011-06-11 16:00
  - exclusion of subject due to vomiting ratnakar1811 2011-06-13 14:06
    - exclusion of subject due to vomiting Ohlbe 2011-06-13 23:13
      - exclusion of subject due to vomiting ratnakar1811 2011-06-14 11:45
        
        exclusion of subject due to vomiting Helmut 2011-06-14 14:11
        
        exclusion of subject due to vomitingratnakar1811 2011-06-15 06:49
        
        exclusion of subject due to vomiting Helmut 2011-06-15 12:03
        
        exclusion of subject due to vomiting ratnakar1811 2011-06-20 06:37
        
        exclusion of subject due to vomiting Helmut 2011-06-20 13:41