Bioequivalence and Bioavailability Forum • Withdrawal Criteria

Dr.Pravin
☆

Ahmedabad,
2006-11-21 10:32
(6749 d 08:35 ago)

Posting: # 367
Views: 5,128

Withdrawal Criteria [Regulatives / Guidelines]

Hi,

Can You please specify the Withdrawal Criteria for BA/BE Study,

Also want to know defrenece between the Drop Out and Withdrawl.

If if subject was drop out of withdraw from the study due to any reason dose any guidline specify that you go for the Analysis of such samples, but do not consider in statastical analysis.

—
Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad

sekhar91
●

2006-11-22 13:36
(6748 d 05:32 ago)

@ Dr.Pravin
Posting: # 369
Views: 3,985

Withdrawal Criteria

Post reply

❝ Can You please specify the Withdrawal Criteria for BA/BE Study,

❝

❝ Also want to know defrenece between the Drop Out and Withdrawl.

❝

❝ If if subject was drop out of withdraw from the study due to any reason dose any guidline specify that you go for the Analysis of such samples, but do not consider in statastical analysis.

Withdrawal: if the investigator decides to discontinue the subject from the study Due to Adverse Event, in this their is two reasons:

subject related
study related reasons.

Dropout: A subject would be considered "dropout" from the study when the subject discontinues the study of his/ her own volition.

if subject was dropped out or withdrawn from the study these samples are not going to be analysed.