Expiry Dates of Biostudies [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2004-10-05 21:04 (6699 d 02:46 ago) – Posting: # 10
Views: 11,268

Dear colleagues!

Although it may be not a good idea to use 'old' studies for a regulatory submission – since scientific progress may be pretty fast – the only national guideline mentioning an 'Expiry Date' for a BA/BE study comes from South Africa, which states at 3.10 (page 13):
'The bioavailability/bioequivalence study should have been completed not longer than five years prior to the date of submission.'

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

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

Complete thread:

UA Flag
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
19 visitors (0 registered, 19 guests [including 13 identified bots]).
Forum time: 22:50 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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