Requirements ⇒ recommendations [BE/BA News]

posted by Obinoscopy  – USA, 2018-08-03 00:59 (2065 d 10:11 ago) – Posting: # 19129
Views: 8,149

❝ Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):


❝ VIII. Glossary, Batch

❝ old:

A batch is a number of unknown samples from one or more patients in a study and QCs that are processed at one time.


❝ new:

For purposes of this guidance, a batch is a number of unknown samples from one or more pati­ents in a study and QCs that are processed at one time.



Wow, thanks. Now I know the reason for the update. No more pondering. Mucho Gracias

Scopy

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
111 visitors (0 registered, 111 guests [including 10 identified bots]).
Forum time: 10:11 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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