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RegisterWHO BTIF [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2012-01-12 14:55 (4481 d 03:05 ago) – Posting: # 7915
Views: 4,985
Dear Kartik!
Thanks for bringing this document to my attention; didn’t know it.
Looking at this table I think that it is less complicated than you think. Ignore the word ‘Interindividual’ and give CV% as the ratio of the two preceding columns with CV%=100·SD/x. Unless the study was performed in a replicate design (specifically: one where both T and R were repeated) it is not possible to calculate CVinter / CVintra separately for the two treatments. Even then you would have to repeat the analysis on untransformed data (which is against the guideline) to approximately (!) match the values in the first two columns.
Although TRS 937, Annex 7 set a milestone back in 2006 (especially for countries lacking their own guidelines) it is not free from errors – like all guidelines, our own reports, and papers published in peer-review journals as well.
P.S.: Section 7.3(b) Period and/or sequence effects of the form is meaningless at all.
❝ according to WHO BTIF(bioequivalence trial information form) in that section 7.4.
Thanks for bringing this document to my attention; didn’t know it.
❝ WHO are asking to compare our study report with reference literature report in that they are asking to calculate intersubject cv how its possible to calculate with mean and standard deviation so please guide me.
Looking at this table I think that it is less complicated than you think. Ignore the word ‘Interindividual’ and give CV% as the ratio of the two preceding columns with CV%=100·SD/x. Unless the study was performed in a replicate design (specifically: one where both T and R were repeated) it is not possible to calculate CVinter / CVintra separately for the two treatments. Even then you would have to repeat the analysis on untransformed data (which is against the guideline) to approximately (!) match the values in the first two columns.
Although TRS 937, Annex 7 set a milestone back in 2006 (especially for countries lacking their own guidelines) it is not free from errors – like all guidelines, our own reports, and papers published in peer-review journals as well.
P.S.: Section 7.3(b) Period and/or sequence effects of the form is meaningless at all.
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Helmut Schütz
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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 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- WHO BTIFHelmut 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
- intrasubject Helmut 2012-01-16 14:50
- intrasubject K2K 2012-01-18 09:36
- intrasubject Helmut 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 BTIFHelmut 2012-01-12 13:55
Ing. Helmut Schütz