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Rosy
Junior

Mexico,
2019-01-21 17:37

Posting: # 19797
Views: 823
 

 PASS Sample Size [Software]

Hello! Anyone who uses PASS software for the Sample size calcultation???


Edit: Category changed; see also this post #1. [Helmut]
ashwinim13
Junior

India,
2019-01-24 12:30

@ Rosy
Posting: # 19802
Views: 632
 

 PASS Sample Size

» Hello! Anyone who uses PASS software for the Sample size calcultation???

I am using PASS from last seven years for BA BE and Phase III trial sample size estimations.Its very good and user friendly software
Rosy
Junior

Mexico,
2019-01-28 23:47

@ ashwinim13
Posting: # 19819
Views: 534
 

 PASS Sample Size

» I am using PASS from last seven years for BA BE and Phase III trial sample size estimations.Its very good and user friendly software.

I know it's easy, i just started to use. is any way to calculate CV intrasubject from IC's of a BE study (like power tost)????
mittyri
Senior

Russia,
2019-01-31 22:45

@ Rosy
Posting: # 19833
Views: 424
 

 FARTSSIE?

Hi Rosy,

» I know it's easy, i just started to use. is any way to calculate CV intrasubject from IC's of a BE study (like power tost)????

If R is not allowed, may be you can try with FARTSSIE?
User-friendly and Excel-based

Kind regards,
Mittyri
Rosy
Junior

Mexico,
2019-02-08 18:01

@ mittyri
Posting: # 19888
Views: 180
 

 FARTSSIE?

Dear Mittyri,

» If R is not allowed, may be you can try with FARTSSIE?
» User-friendly and Excel-based

Sorry i did't see this post reply, thank u so much.

Kind Regards
BE-proff
Senior

Russia,
2019-01-24 13:33

@ Rosy
Posting: # 19803
Views: 628
 

 PASS Sample Size

Hi Rosy,

It is better to use PowerTOST for bioequivalence.
PASS is good for clinical endpoints studies.
Rosy
Junior

Mexico,
2019-01-28 23:52

@ BE-proff
Posting: # 19820
Views: 534
 

 PASS Sample Size

» It is better to use PowerTOST for bioequivalence.
» PASS is good for clinical endpoints studies.

I know, i really like PowerTOST and also is free but my regulation ask for the use of "Confidence Software" then i chose to use PASS because the friendly interfase
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2019-01-29 03:54

@ Rosy
Posting: # 19821
Views: 530
 

 Confidence [?] software

Hi Rosy,

» […] my regulation ask for the use of "Confidence Software" …

We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please?

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Rosy
Junior

Mexico,
2019-01-31 19:10

@ Helmut
Posting: # 19831
Views: 448
 

 Confidence [?] software

» We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please?

Dear Helmut,

There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed :-|
ElMaestro
Hero

Denmark,
2019-01-31 21:43

@ Rosy
Posting: # 19832
Views: 425
 

 Confidence [?] software

Hi Rosy,

» There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed :-|

I have no idea where such a recommendation would come from? Maybe you can try EFG??
As I recall it, it was written by a former regulator and it only handles the standard design with any level of credibility (and I am not saying any high level of credibility).

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1



Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
Rosy
Junior

Mexico,
2019-02-01 20:51
(edited by Rosy on 2019-02-02 01:29)

@ ElMaestro
Posting: # 19837
Views: 361
 

 Confidence [?] software

Dear ElMaestro,

» I have no idea where such a recommendation would come from?

I work at CRO, and this recommendation came from the health authority in Mexico (specifically during an audit), so we had to acomplish it.

» As I recall it, it was written by a former regulator and it only handles the standard design with any level of credibility (and I am not saying any high level of credibility).

Thank u so much, i will try it.

Kind Regards :)
d_labes
Hero

Berlin, Germany,
2019-02-02 13:50

@ Rosy
Posting: # 19842
Views: 317
 

 R software is not allowed in Mexi­co?

Dear Rosy,

» » We had already some problems in interpreting Mexican requirements. Can you give the complete sentence in Spanish, please?
»
» There is not sentence, this was an spoken recommendation, nothing written. In a few words: R software is not allowed :-|
emphasis by me - dlabes

IMHO such an statement is absolutely nonsense or at least outright bizarre.
Much more bizarre is the fact that there is no written statement about such a recommendation.

Regarding the regulatory acceptance of PowerTOST in other jurisdictions you may find this thread.
Look into this post to find what an opinion the FDA has regarding the use of the R language at all.

Maybe this gives you some arguments which help in an other audit to convince the auditor(s) in respect of using R packages.

Any other Mexican member out there with same observation?

Regards,

Detlew
Rosy
Junior

Mexico,
2019-02-06 17:43

@ d_labes
Posting: # 19884
Views: 270
 

 R software is not allowed in Mexi­co?

Dear d_labes:

» Maybe this gives you some arguments which help in an other audit to convince the auditor(s) in respect of using R packages.

thank u, i hope Mexican authorities can understand that.
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