jag009
★★★

NJ,
2024-07-12 18:04
(117 d 14:22 ago)

Posting: # 24071
Views: 844
 

 Need some clarity on eCTD module 5 [Regulatives / Guidelines]

Hi,

Sorry if this is off-topic but can someone shed some light on the following?

There is inadequate or incorrect use of Study Tagging Files (STF).
1) The following folders and its subsequent files in module 5.3.1.4 should be tagged, using the proper file-tag element under one applicable study:

bioananlytical report for compound A
bioanalytical report for compound B


Can someone share an example of how the above should be done?
thx
J
UA Flag
Activity
 Admin contact
23,288 posts in 4,890 threads, 1,661 registered users;
94 visitors (1 registered, 93 guests [including 12 identified bots]).
Forum time: 07:26 CET (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5