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RegisterISR for pilot study [Bioanalytics]
Dear All,
Highly appreciate your inputs on the questions below.
(i) Is ISR necessary for pilot study ?
(2) For BE study using pharmacodynamic parameters, for example measurement of serum glucose level performed by pathology lab, what are the parameters to be performed in method validation ? The instrument and approach used for glucose determination in pathology lab is different from analytical lab. Limited (2 levels) standard reagents are used and no QC samples.
Thank you.
Regards,
Ken
Highly appreciate your inputs on the questions below.
(i) Is ISR necessary for pilot study ?
(2) For BE study using pharmacodynamic parameters, for example measurement of serum glucose level performed by pathology lab, what are the parameters to be performed in method validation ? The instrument and approach used for glucose determination in pathology lab is different from analytical lab. Limited (2 levels) standard reagents are used and no QC samples.
Thank you.
Regards,
Ken
Complete thread:
- ISR for pilot studyKen Peh 2014-04-11 16:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ISR for pilot study jag009 2014-04-11 17:50
- ISR for pilot study Ohlbe 2014-04-11 17:59
- ISR for pilot study jag009 2014-04-11 21:44
- ISR for pilot study Ken Peh 2014-04-12 08:32
- ISR for pilot study jag009 2014-04-11 21:44
Ing. Helmut Schütz