Regarding completion of period from a subject [GxP / QC / QA]

posted by vivekanand – India, 2012-11-16 12:47 (4557 d 01:36 ago) – Posting: # 9539
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Dear All

In a BA/BE study,when can we consider the subject not completed period in following cases
  1. If a subject after dosing with drawn from a study in period-01 before check-out (in house stay). Then he/she shall be considered as period-not completed -is this yes/no.
  2. If a subject is with drawan from the study during wasout period of drug or during ambulatory sample visits for any AE.Then he/she shall be considered as period-not completed (for the period which they were dosed) -is this yes/no.

Regards
G.Balavivekanand

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