Bioequivalence and Bioavailability Forum • Regarding completion of period from a subject

vivekanand
☆

India,
2012-11-16 12:47
(4962 d 09:02 ago)

Posting: # 9539
Views: 5,827

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

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Dear All

In a BA/BE study,when can we consider the subject not completed period in following cases

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.
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

drgunasakaran1
★★

2012-11-16 16:51
(4962 d 04:58 ago)

@ vivekanand
Posting: # 9543
Views: 4,630

Regarding completion of period from a subject

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Dear Mr Vivekanand,

❝ I. 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.

No. The period will not be considered as "Completed"

❝ II. 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.

If withdrawn during wash out period:
Yes. Usually, will be considered as that particular period is completed for the subject.

If withdrawn during ambulatory sample visits:
No. Should be considered as "Period Not completed"

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn