Log in
RegisterBE study with two different batches of the reference product [Study Assessment]
Dear tarak_desai,
Forgive me for saying this, I know this could be seen as a negative comment; But do you really think it is a good idea to proceed with this trial if you realise halfway through it that you have not been able to plan it well enough to have the Ref available in quantities sufficing for the number of subjects?
It sounds to me like the planning is completely off. Think about responsibilities, futile trials, drug accountability, and GCP.
(let me add: an argument of having to involve a new Ref batch to avoid the trial becoming futile strikes me as backward)
❝ 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?
Forgive me for saying this, I know this could be seen as a negative comment; But do you really think it is a good idea to proceed with this trial if you realise halfway through it that you have not been able to plan it well enough to have the Ref available in quantities sufficing for the number of subjects?
It sounds to me like the planning is completely off. Think about responsibilities, futile trials, drug accountability, and GCP.
(let me add: an argument of having to involve a new Ref batch to avoid the trial becoming futile strikes me as backward)
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- BE study with two different batches of the reference product tarak_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 productElMaestro 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