WHO TRS 937, Annex 7? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-10-18 16:00 (5733 d 23:47 ago) – Posting: # 6059
Views: 4,202

Dear D. Labes!

❝ ❝ [b][/b][big][/big][color:blue][/color:blue]

:confused: Whats your hidden message?


Easy - didn't find the [image] button...

❝ Seems there are no distinct regulations despite some general statements.


THX for googling; I added it to the Guidelines. Maybe WHO's GL is applicable in the meantime, following a converse argument of the GL on Variations (2009):

Justification for not submitting a new bioequivalence study according to the current WHO guideline, in: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth report, 2006, Annex 7 (WHO Technical Report Series, No. 937) and Good Clinical Practices.


Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,571 registered users;
268 visitors (0 registered, 268 guests [including 19 identified bots]).
Forum time: 15:48 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

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