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

posted by Mahesh M - India, 2017-07-06 06:45  - Posting: # 17512
Views: 541

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

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