Bioequivalence and Bioavailability Forum • multiple dose steady state BE and emesis criteria

multiple dose steady state BE and emesis criteria [Regulatives / Guidelines]

posted by Mahesh M – India, 2017-07-06 08:45 (3276 d 03:24 ago) – Posting: # 17512
Views: 8,616

Dear All,

Please suggest, for multiple dose steady state BE study(day 1 -5), If any subject vomit between the day 1-2 and 1-4, what will be the withdrawal criteria? If steady state achive in three days and emesis occur on day one or day two should we continue the subjects.

Regards
M

Complete thread:

multiple dose steady state BE and emesis criteriaMahesh M 2017-07-06 06:45
- multiple dose steady state BE and emesis criteria Mahesh M 2017-07-14 12:31
  - multiple dose steady state BE and emesis criteria jag009 2017-07-20 05:15
    - regression of pre-dose concentrations Helmut 2017-07-22 15:12
      - Which method for SS achievement? mittyri 2017-07-23 11:52
- IR and MR: pre-specified! Helmut 2017-07-22 15:33