Log in
RegisterRetained samples? [Study Assessment]
Hi Vishal K,
furthermore, if by any chance the CRO has retained samples from the two trials (i.e. units that were undispensed, unused) then I would ask those back and subject them to the usual in vitro tests that you use for the CoA, most importantly
1. potency or content.
2. the release profiles in suitable dissolution media.
furthermore, if by any chance the CRO has retained samples from the two trials (i.e. units that were undispensed, unused) then I would ask those back and subject them to the usual in vitro tests that you use for the CoA, most importantly
1. potency or content.
2. the release profiles in suitable dissolution media.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Pivotal and pilot BE Study K Vishal 2017-07-07 11:17 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pivotal and pilot BE Study ElMaestro 2017-07-07 12:05
- Pivotal and pilot BE Study Ohlbe 2017-07-07 18:29
- Pivotal and pilot BE Study K Vishal 2017-07-08 09:23
- Pivotal and pilot BE Study Helmut 2017-07-08 14:23
- Retained samples?ElMaestro 2017-07-08 17:01
- Pivotal and pilot BE Study K Vishal 2017-07-08 09:23
Ing. Helmut Schütz