ioanam
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Romania,
2010-11-23 14:48
(5265 d 01:49 ago)

Posting: # 6197
Views: 5,815
 

 replicate study [Software]

Dear all,
please give me an advice related to the most appropriate software to be used (except PROC GLM in SAS) for statistical analysis in a replicate crossover study.
Can you tell me if ANOVA in Kinetica software is a good choice?
Thank you.
Helmut
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Vienna, Austria,
2010-11-23 16:25
(5265 d 00:12 ago)

@ ioanam
Posting: # 6201
Views: 5,109
 

 replicate study

Dear Jo!

❝ Can you tell me if ANOVA in Kinetica software is a good choice?


Hey, we had that already. ;-) The answer is no.
Phoenix/WinNonlin is an alternative (we checked an example dataset assesed by FDA's SAS-code at Pharsight's Extranet) - but I would wait until EMA publishes their SAS-code for replicate studies (which will include a sample dataset).

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ioanam
★    

Romania,
2010-11-23 16:39
(5264 d 23:59 ago)

@ Helmut
Posting: # 6202
Views: 4,998
 

 replicate study

Dear Helmut!
I forgot about this post and I have some data that I can not evaluate. So, I'm trying to find solution.

Thank you very much for remembering me :-)
Ioana
Helmut
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Vienna, Austria,
2010-11-23 16:47
(5264 d 23:50 ago)

@ ioanam
Posting: # 6204
Views: 5,018
 

 replicate study

Dear Ioana!

❝ I'm trying to find solution.


If you don’t want to purchase Phoenix/WinNonlin consider package bear for R (freeware).

For some related discussions browse the forum’s category R for BE/BA. The developers (Hsin-ya Lee & Yung-jin Lee) are active members of the forum…

❝ Thank you very much for remembering me


How could I forget you?

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ioanam
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Romania,
2010-11-23 16:43
(5264 d 23:54 ago)

@ Helmut
Posting: # 6203
Views: 4,984
 

 replicate study

Dear Helmut

do you think that EMA will publish SAS for replicate studies?

Thank you again
Helmut
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Vienna, Austria,
2010-11-23 16:50
(5264 d 23:47 ago)

@ ioanam
Posting: # 6206
Views: 5,014
 

 replicate study

Dear Ioana!

❝ do you think that EMA will publish SAS for replicate studies?


Definitely yes. Last month in Munich two members of the PK group told me that the document is already finalized – we are all waiting for being published at EMA’s website.


Edit: Published 14 Mar 2011 (see here). [Helmut]

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d_labes
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Berlin, Germany,
2010-11-23 16:49
(5264 d 23:48 ago)

@ ioanam
Posting: # 6205
Views: 5,038
 

 (R)eplicate study evaluation

Dear Io,

replicate designs were handled in SAS usually by calling Proc MIXED, not Proc GLM.

Beside commercial software like Helmut's recommendation you can try R's add-on package nlme, function lme() or use bear which has implemented the evaluation of replicate studies (but only 2-sequence replicate crossover designs). via lme().

The estimates of the parameters of interest, namely the difference T-R and the intra-individual variabilities, are the same as in SAS, FDA code.

But the degrees of freedom for the effects tested are different and therefore also the 90% confidence intervals derived. See this thread for a discussion.

With 'enough' subjects the difference is usually not so marked. But don't know how the regulatory acceptance is.

Hope this helps.

Regards,

Detlew
ioanam
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Romania,
2010-11-23 17:11
(5264 d 23:26 ago)

@ d_labes
Posting: # 6207
Views: 5,013
 

 (R)eplicate study evaluation

Thank you all for helping me everytime!

Ioana
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