Bioequivalence and Bioavailability Forum • exclusion of subject due to vomiting

exclusion of subject due to vomiting [Regulatives / Guidelines]

posted by ratnakar1811 – India, 2011-06-20 08:37 (5485 d 18:03 ago) – Posting: # 7155
Views: 11,365

Dear HS,
Thanks for your inputs;

❝ Withdraw a subject if vomiting occurs according to FDA’s rules. Analyze samples – regardless the treatment.

❝

If vomiting occurs outside the limits stated for IR and MR formulations it’s upon the investigator’s destinction whether to keep the subject in the study or not.

My concern is current EU guideline specifically mention about the decesion to withdraw a subject should be taken before analysis & this should not creat any issues later on, as I got a study where withdrwing a subject at statistical analysis stage reverse the results of the study?

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 vomiting ratnakar1811 2011-06-15 06:49
        
        exclusion of subject due to vomiting Helmut 2011-06-15 12:03
        
        exclusion of subject due to vomitingratnakar1811 2011-06-20 06:37
        
        exclusion of subject due to vomiting Helmut 2011-06-20 13:41