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RegisterIncurred sample analysis [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2008-03-11 16:30 (6677 d 01:54 ago) – Posting: # 1683
Views: 4,857
Dear Ohlbe!
Though the requirement of 15% incurred samples was removed from the guidelines in 2003, Health Canada on 09 Jan 2008 published a Notice: Replication of Incurred Samples in Bioavailablity/Bioequivalence Studies requesting '[...] a voluntary submission of data collected on replicate samples since 2000. [...] This information will be used for research purposes only and will in no way affect past regulatory decisions. [...] Release of the information will be limited to summary statistics, with no linkage between the sponsor and the data.'
HPB hopes '... to be able to present our findings at the next Canadian Workshop on Recent Issues in GLP Bioanalysis on April 17-18, 2008 in Montreal.'
❝ [...] only lots of discussions.
Though the requirement of 15% incurred samples was removed from the guidelines in 2003, Health Canada on 09 Jan 2008 published a Notice: Replication of Incurred Samples in Bioavailablity/Bioequivalence Studies requesting '[...] a voluntary submission of data collected on replicate samples since 2000. [...] This information will be used for research purposes only and will in no way affect past regulatory decisions. [...] Release of the information will be limited to summary statistics, with no linkage between the sponsor and the data.'
HPB hopes '... to be able to present our findings at the next Canadian Workshop on Recent Issues in GLP Bioanalysis on April 17-18, 2008 in Montreal.'
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Incurred sample analysis sri 2008-02-28 08:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Incurred sample analysis Ohlbe 2008-02-28 10:08
- Incurred sample analysisHelmut 2008-03-11 15:30
- Incurred sample analysis Ohlbe 2008-03-11 19:10
- Incurred sample analysisHelmut 2008-03-11 15:30
- Incurred sample analysis Ohlbe 2008-02-28 10:08
Ing. Helmut Schütz