Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 18:10 (683 d 06:06 ago) – Posting: # 20029
Views: 3,208

Dear Osama,

» Please think about very big clinical trials which required a multi-centers ( e.g for Anti-cancer drugs), you deal here with different CRO's which could have different technologies.

BE trials in patients are indeed usually multi-centre trials. But multiple clinical sites does not mean there has to be multiple bioanalytical labs (unless the analyte is so unstable the samples cannot even afford to be shipped to a central lab ? I don't have any practical example in mind).

The one difficulty could be if due to the study duration the lab closes down half-way through the study and a new lab has to be used.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,310 posts in 4,445 threads, 1,489 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Monday 00:17 UTC (Europe/Vienna)

Science may set limits to knowledge,
but should not set limits to imagination.    Bertrand Russell

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