Bioequivalence and Bioavailability Forum • Drowsiness

Drowsiness [Regulatives / Guidelines]

posted by Rajdoc – India, 2014-03-11 13:08 (4488 d 19:37 ago) – Posting: # 12590
Views: 5,003

Hi all

For most of the antipsychotics drowsiness is a common side effect, and some times it could be 100 %. what are the options we have when the drowsiness is 100 % in a study, Do we have to report individually????

Drowsiness is a side effect and extension of a pharmacodynamic effect so is it really necessary to report it as an AE

Complete thread:

DrowsinessRajdoc 2014-03-11 12:08
- TEAE Helmut 2014-03-11 13:40
  - TEAE Rajdoc 2014-03-12 07:06
    - TEAE Ohlbe 2014-03-12 14:17
    - TEAE Helmut 2014-03-12 16:53
      - TEAE ElMaestro 2014-03-12 17:17
        
        OT Helmut 2014-03-12 17:38
  - AE definition in BEQ study mittyri 2014-03-13 20:40
    - Great post! Helmut 2014-03-14 14:39