#2
| |||
| |||
Re: NDA submission requirements
I am here by providing you the ZIP file that contain the sample NDA Submission. This ZIP file contain • folder structure for an NDA submission • table of contents for the NDA • table of contents with bookmarks for cmc, nonclinical pharmtox, clinstat, crt, crt datasets, crt profiles, crf • table of contents for hpbio and micro (no bookmarks) • study report bookmarks (clinstat/pneumo/1234.pdf) • document information fields for labels and crf, publications (pharmtox and clinstat) • full text index (crf/crfindex.pdx) • data definition file for nonclinical data (pharmtox/datasets/101/define.pdf) • dataset for tumors from a carcinogenicity study (pharmtox/datasets/101/tumor.xpt) • data definition file for clinical data (crt/datasets/1234/define.pdf) • dataset for efficacy data (crt/datasets/1234/efficacy.xpt) • partial bookmarks for crf (crf/101/001/112.pdf) |
Similar Threads | ||||
Thread | Thread Starter | Forum | Replies | Last Post |
Last Date of MBA CET Form Submission | mamta | Online MBA Discussions | 2 | 7th March 2018 12:35 PM |
Last Date for Submission of TNEA | Unregistered | Main Forum | 1 | 10th June 2017 02:10 PM |
KVPY Online Form Submission | Unregistered | Main Forum | 1 | 1st November 2016 04:06 PM |
Online Submission of CDS Exam | Unregistered | Main Forum | 0 | 16th July 2015 03:41 PM |
DSSSB Fee Submission | Unregistered | Main Forum | 0 | 14th July 2015 03:48 PM |
AIPMT Submission Form | Unregistered | Main Forum | 0 | 13th July 2015 01:29 PM |
UPCPMT Online Form Submission | Unregistered | Main Forum | 0 | 9th July 2015 12:12 PM |
CPMT Forms Submission Dates | Unregistered | Main Forum | 1 | 27th October 2014 04:57 PM |
IIT JEE Forms Submission Last Date | Unregistered | Main Forum | 1 | 21st October 2014 03:46 PM |
Process for Online Form and Fee Submission | Unregistered | Main Forum | 1 | 20th October 2014 04:24 PM |
MAT Last date for the submission for forms | Unregistered | Main Forum | 1 | 18th October 2014 11:55 AM |
After Submission Form How to get Registration Number | Unregistered | Main Forum | 1 | 15th October 2014 03:25 PM |
UGC NET form Submission Last Date | Unregistered | Main Forum | 1 | 15th October 2014 01:53 PM |
UP Polytechnic Form Submission Date | Unregistered | Main Forum | 1 | 8th October 2014 02:17 PM |
B.Ed CET Exam Form Submission Date | Unregistered | Main Forum | 1 | 8th October 2014 12:47 PM |
Nda last date of form submission | Devenb | Main Forum | 1 | 5th April 2013 04:31 PM |
IGNOU MBA Assignment Submission Date | Pramod ak | Main Forum | 1 | 15th March 2013 11:19 AM |
PTU last date of submission of MBA application form | Sridharas | Main Forum | 1 | 10th February 2013 04:43 PM |
UGC Online Submission | ja.fotoh.h | Main Forum | 1 | 19th October 2012 12:58 PM |
GNLU Law Review Submission | noor.4 | Main Forum | 1 | 27th August 2012 04:56 PM |
Thread Tools | Search this Thread |
|