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Registerintrasubject [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2012-01-16 15:50 (5277 d 11:47 ago) – Posting: # 7950
Views: 6,549
Dear Karthik!
OK, we had that before. That’s not correct, but calculate it according to their form anyhow.
I guess your CVintra is (much?) lower than the one given in literature? If published studies were not using an awful bioanalytical method (high CV) WHO might be suspicious that something went wrong in the study, e.g., conversion of a metabolite to the parent in the ion-source in LC/MS-MS. Since metabolites generally have lower CVs that the parent you will get a lower CV than with a method which separates parent & metabolites. Are your mean concentrations substantially higher than in the literature? If yes, get prepared for an inspection.
❝ they asked to calculate both intrasubject and intersubject CV.
❝ for intersubject they asked to calculate from art.mean and std dev.
OK, we had that before. That’s not correct, but calculate it according to their form anyhow.
❝ for intrasubject they given the statement like that
❝ according to the query 'the intrasubject variability in the reference literature is not consistent with your value'
I guess your CVintra is (much?) lower than the one given in literature? If published studies were not using an awful bioanalytical method (high CV) WHO might be suspicious that something went wrong in the study, e.g., conversion of a metabolite to the parent in the ion-source in LC/MS-MS. Since metabolites generally have lower CVs that the parent you will get a lower CV than with a method which separates parent & metabolites. Are your mean concentrations substantially higher than in the literature? If yes, get prepared for an inspection.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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:
- WHO BTIF K2K 2012-01-12 05:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WHO BTIF Helmut 2012-01-12 13:55
- WHO BTIF K2K 2012-01-13 05:51
- WHO BTIF Helmut 2012-01-13 17:05
- WHO BTIF Ohlbe 2012-01-13 18:41
- WHO BTIF Helmut 2012-01-13 18:54
- WHO BTIF K2K 2012-01-16 12:51
- Inter- or intra-subject CV? Helmut 2012-01-16 13:26
- intrasubject K2K 2012-01-16 13:35
- intrasubjectHelmut 2012-01-16 14:50
- intrasubject K2K 2012-01-18 09:36
- intrasubjectHelmut 2012-01-16 14:50
- intrasubject K2K 2012-01-16 13:35
- Inter- or intra-subject CV? Helmut 2012-01-16 13:26
- WHO BTIF K2K 2012-01-16 12:51
- WHO BTIF Helmut 2012-01-13 18:54
- WHO BTIF Ohlbe 2012-01-13 18:41
- WHO BTIF Helmut 2012-01-13 17:05
- WHO BTIF K2K 2012-01-13 05:51
- WHO BTIF Helmut 2012-01-12 13:55
Ing. Helmut Schütz