EMA BE-GL: Clarifications / Corrections? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2010-06-22 20:53 (5448 d 23:10 ago) – Posting: # 5551
Views: 42,963

Dear all,

according to rumours at the recent Workshop in Budapest (235 participants!) EMA started an initiative involving the PK-Drafting Group and the Biostatistics Drafting Group of EWP to clarify/correct some open issues of the new BE-GL.
Points under discussion areWe can expect not only SAS-code, but example data-sets in order to validate other software.

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
23,424 posts in 4,927 threads, 1,681 registered users;
44 visitors (0 registered, 44 guests [including 31 identified bots]).
Forum time: 20:03 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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