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Registermultiple dose steady state BE and emesis criteria [Regulatives / Guidelines]
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
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 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- regression of pre-dose concentrations Helmut 2017-07-22 15:12
- multiple dose steady state BE and emesis criteria jag009 2017-07-20 05:15
- IR and MR: pre-specified! Helmut 2017-07-22 15:33
- multiple dose steady state BE and emesis criteria Mahesh M 2017-07-14 12:31
Ing. Helmut Schütz