Bioequivalence and Bioavailability Forum • Adverse event

Adverse event [Regulatives / Guidelines]

posted by Rameswari jena – India, 2013-10-30 12:51 (4622 d 10:29 ago) – Posting: # 11812
Views: 4,010

Hello ,

Can anyone clarify my doubt? Its urgent? In one of our study one subject was dosed at 09:06 and he got vomiting at 09:20. The Cmax of the drug was between 30min-6 hrs (median 2 hrs). Finally the subject was withdrwn from the study but the AE was given as not related with the drug? Plz Justify?

Complete thread:

Adverse eventRameswari jena 2013-10-30 11:51
- Adverse event ElMaestro 2013-10-30 12:15
  - Adverse event Rameswari jena 2013-10-30 12:49
    - Adverse event ElMaestro 2013-10-30 13:27
    - Adverse event Dr_Dan 2013-10-30 14:48
  - Adverse event jag009 2013-10-30 14:59
- Adverse event Rameswari jena 2013-10-31 06:09