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RegisterBE study with two different batches of the reference product [Study Assessment]
Hello to all,
Need your guidance on following case.
In a two period, single dose, cross over, BE study, it was observd that after completion of period-I, there was insufficient quantity of the reference product available to dose subjects in period-II. sponsor also doesnt have same batch reference product availalbe with them.
can we use the different batch reference product in priod-II?
and what other measures to be taken in this case?
or redosing to be done using same batch in period-I and II or do we need to cancel study?
pls guide.
thanks.
tarak
Edit: Category changed. [Helmut]
Need your guidance on following case.
In a two period, single dose, cross over, BE study, it was observd that after completion of period-I, there was insufficient quantity of the reference product available to dose subjects in period-II. sponsor also doesnt have same batch reference product availalbe with them.
can we use the different batch reference product in priod-II?
and what other measures to be taken in this case?
or redosing to be done using same batch in period-I and II or do we need to cancel study?
pls guide.
thanks.
tarak
Edit: Category changed. [Helmut]
Complete thread:
- BE study with two different batches of the reference producttarak_desai 2014-12-16 06:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study with two different batches of the reference product cher0424 2014-12-16 07:31
- BE study with two different batches of the reference product ElMaestro 2014-12-16 09:01
- BE study with two different batches of the reference product cher0424 2014-12-16 09:31
- Two different batches of R: bad idea Helmut 2014-12-16 13:36
- Two different batches of R: Analysis separately?? cher0424 2014-12-17 01:49
- Two different batches of R: very bad idea Ohlbe 2014-12-17 13:45
- Forget it! Helmut 2014-12-17 14:49
- Forget it! cher0424 2014-12-18 01:08
- Two different batches of R: Analysis separately?? cher0424 2014-12-17 01:49
- Two different batches of R: bad idea Helmut 2014-12-16 13:36
- BE study with two different batches of the reference product cher0424 2014-12-16 09:31
- BE study with two different batches of the reference product jag009 2014-12-16 15:24
- BE study with two different batches of the reference product felipeberlinski 2014-12-17 20:16
Ing. Helmut Schütz