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RegisterRedosing study… [Study Assessment]
Hello All,
We did a Pivotal study… sample size: 26.
It failed in cmax due to one subject whose T/R=300% due to reference formulation.
we are planning a redosing study to see if the data of this subject was
abberant or not…
In redosing study we are planning to go with 6 subjects. equal TR and RT sequence
Ques1) Can we mention in protocol that we will take sub no 1, 4, 8, 9, 14, 22 in the redosing study or it will stand as a selection bias. This is bcoz the ratio of these subs are near to unity. This will help in making our control arm in study more strong.
Ques 2) What shall be the range of data wherein if the redosing data of postulated outlier falls, then it can be considered as abberant observation.
Edit: Category changed. [Helmut]
We did a Pivotal study… sample size: 26.
It failed in cmax due to one subject whose T/R=300% due to reference formulation.
we are planning a redosing study to see if the data of this subject was
abberant or not…
In redosing study we are planning to go with 6 subjects. equal TR and RT sequence
Ques1) Can we mention in protocol that we will take sub no 1, 4, 8, 9, 14, 22 in the redosing study or it will stand as a selection bias. This is bcoz the ratio of these subs are near to unity. This will help in making our control arm in study more strong.
Ques 2) What shall be the range of data wherein if the redosing data of postulated outlier falls, then it can be considered as abberant observation.
Edit: Category changed. [Helmut]
Complete thread:
- Redosing study…H.Patel 2011-06-15 16:28
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Redosing study… swapnil.kuche 2011-06-16 08:35
- Redosing study… Dr_Dan 2011-06-16 12:37
- Redosing study… Helmut 2011-06-16 12:52
- Redosing study… GSTATS 2011-06-16 16:12
- Redosing study… luvblooms 2011-06-17 06:34
- Redosing study… ElMaestro 2011-06-17 09:16
- Redosing study… luvblooms 2011-06-17 12:50
- Redosing study… ElMaestro 2011-06-17 13:09
- Redosing study… luvblooms 2011-06-18 11:47
- Redosing study… GSTATS 2011-06-17 16:57
- Redosing study… luvblooms 2011-06-18 11:53
- Redosing study… ElMaestro 2011-06-17 13:09
- Redosing study… luvblooms 2011-06-17 12:50
- Redosing study… ElMaestro 2011-06-17 09:16
- Redosing study… Dr_Dan 2011-06-16 12:37
- Redosing study… swapnil.kuche 2011-06-16 08:35
Ing. Helmut Schütz