Log in
RegisterRandomisation? [Study Performance]
Hi ElMaestro & Helmut
I think that it's important to have randomisation of subject 15 (I dont now the basis of a software (kinetica) and how tu use it), I havnt randomisation because they dont give me it, they asked me to try to understand where is the error, so when I search I found that oeprazole is a HVDP and I try to understand what FDA and EMA do, I concluded that our design is't appropriate (must have replicate design), but with Phoenix/WinNonlin CV=23.37%, so the problem of our study is number of subject, with hightest number we can conclude to biequivalence (the test drug is really bioequivalent of réference, this study was done to learn how to do biequivalennce study)
I calculated CV with error = 0.0471261 and I had CV% = 100√(ℯ0.0471261 – 1) = 21.97% but I thought that I was wrong
I think that it's important to have randomisation of subject 15 (I dont now the basis of a software (kinetica) and how tu use it), I havnt randomisation because they dont give me it, they asked me to try to understand where is the error, so when I search I found that oeprazole is a HVDP and I try to understand what FDA and EMA do, I concluded that our design is't appropriate (must have replicate design), but with Phoenix/WinNonlin CV=23.37%, so the problem of our study is number of subject, with hightest number we can conclude to biequivalence (the test drug is really bioequivalent of réference, this study was done to learn how to do biequivalennce study)
I calculated CV with error = 0.0471261 and I had CV% = 100√(ℯ0.0471261 – 1) = 21.97% but I thought that I was wrong
Complete thread:
- randomization khaoula 2014-06-06 14:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Imbalanced cross-overs Helmut 2014-06-06 14:47
- Imbalanced cross-overs khaoula 2014-06-06 16:03
- CV 0.03%? Helmut 2014-06-07 13:52
- Imbalanced cross-overs jag009 2014-06-09 15:36
- Imbalanced cross-overs khaoula 2014-06-09 22:07
- Bag full of bugs Helmut 2014-06-10 00:37
- Randomisation? ElMaestro 2014-06-10 01:00
- Randomisation? Helmut 2014-06-10 14:53
- Randomisation?khaoula 2014-06-11 00:17
- Problems resolved? Helmut 2014-06-11 02:01
- Problems resolved? khaoula 2014-07-24 13:36
- corrected data in PHX/WNL Helmut 2014-07-27 01:37
- Problems resolved? khaoula 2014-07-24 13:36
- Problems resolved? Helmut 2014-06-11 02:01
- Randomisation?khaoula 2014-06-11 00:17
- Randomisation? Helmut 2014-06-10 14:53
- Randomisation? ElMaestro 2014-06-10 01:00
- Which version of Kinetica? Helmut 2014-06-11 19:51
- Which version of Kinetica? khaoula 2014-06-12 00:41
- Which version of Kinetica? khaoula 2014-07-25 00:49
- adjusted means (aka LSMs) Helmut 2014-07-27 02:23
- adjusted means (aka LSMs) khaoula 2014-08-25 21:41
- adjusted means (aka LSMs) Helmut 2014-07-27 02:23
- Bag full of bugs Helmut 2014-06-10 00:37
- Imbalanced cross-overs khaoula 2014-06-09 22:07
- Imbalanced cross-overs khaoula 2014-06-06 16:03
- Imbalanced cross-overs Helmut 2014-06-06 14:47
Ing. Helmut Schütz