Bioequivalence and Bioavailability Forum

Nirali ★ India, 2013-08-16 10:03 (4691 d 12:54 ago) Posting: # 11291 Views: 5,628	FDA acceptance on software R [Software] Post reply
	Dear All, Can anyone confirm (with sure experience only) are the R programmed outputs accepted by FDA or other regularities with proper validation also available to support the results ? — Nirali Mehta (PHARMA-STATS)

d_labes
★★★

Berlin, Germany,
2013-08-16 10:27
(4691 d 12:31 ago)

@ Nirali
Posting: # 11292
Views: 4,703

FDA acceptance on software R

Post reply

Dear Nirali,

I myself have no sure experience since seldom worked for an FDA submission and always stuck with SAS. Additional said sure is a term which should be avoided in the context of regulatory acceptance :cool:

. Have a look at ElMaestros signature.

But have a look at this blog "Analyzing clinical trial data with R" or this blog and the documents linked there to get some valuable informations about that topic from an R-viewpoint.

See also "Using R: Perspectives of a FDA Statistical RevieweR" to get the key message "The Food and Drug Administration does not endorse or require use of any specific software".

Hope this helps.

—
Regards,

Detlew

Nirali ★ India, 2013-08-16 10:35 (4691 d 12:22 ago) @ d_labes Posting: # 11293 Views: 4,703	FDA acceptance on software R Post reply
	Thank You Sir. — Nirali Mehta (PHARMA-STATS)

FDA acceptance on software R [Software]

FDA acceptance on software R

FDA acceptance on software R