NONMEM Users Network Archive

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RE: Format for submission to FDA

From: MIDO <doddsm>
Date: Mon, 29 Jun 2009 15:20:47 -0700


I would also be very interested in your responses. Recently, we've attempt=
ed to submit a Berkeley Madonna file as part of a submission, and that file=
 type has caused some problems. While it is possible to take the BM code o=
ut as a flat .txt and the embedded data set out as a .csv or .xls (or even =
.xpt, I suppose), I questioned the utility of that. "Reconstituting" the a=
nalysis from the components might be possible here, but it's error prone an=
d, frankly, inefficient.

In the end, we were able to simple embed the BM file (extension .mmd) into =
the eCTD format and send it along. Someone without the BM tool installed o=
n their computer would receive a puzzled response from their web browser wh=
en trying to open the file. However, someone with the tool installed is ab=
le to correctly open the BM file.

Again, comments from our regulatory colleagues would be very helpful here. =
 How can we package and transport complex analysis (my example was single B=
M file, Dennis suggests a series of NONMEM runs in a file structure) and sh=
are that with regulatory bodies?

Mike Dodds

-----Original Message-----
From: owner-nmusers
 Behalf Of Dennis Fisher
Sent: Monday, June 29, 2009 1:36 PM
To: nmusers
Subject: [NMusers] Format for submission to FDA


One of my clients is approaching submission of an NDA to FDA. I did
the pop PK analysis; the files that I generated are in three formats -
text, PDF, and csv. NONMEM text output is saved in two formats (text
and PDF); NONMEM tables are saved in two formats (text and csv);
graphics created in R are saved in PDF format. Datasets used for each
step of the analysis are archived in two formats, text (an exact copy
of the input file plus an exact copy of the FDATA file) and csv (the
FDATA file formatted as csv).

Our plan (based on my other recent submissions to FDA, none of which
has elicited any complaints from them), was to submit these documents
in the formats described above. However, my client received a request
from FDA that:
        "datasets [used in the analysis] should be submitted as SAS transport
(*.xpt) files".
In addition, the company managing the submission wants to convert all
my other csv files to xpt format (although there was no specific
request for this).

Can anyone (particularly anyone at FDA) clarify this for me? In that
NONMEM will not accept .xpt files, I am surprised that FDA would want
datasets in that format. Should my client honor the request or should
they explain to the project manager that NONMEM requires text files so
we plan to submit these files in text format (either .txt or csv).

Thanks for any insights on this.


Dennis Fisher MD
P < (The "P Less Than" Company)
Phone: 1-866-PLessThan (1-866-753-7784)
Fax: 1-415-564-2220

Received on Mon Jun 29 2009 - 18:20:47 EDT

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