Multiple methods within a single trial [Regulatives / Guidelines]

posted by wienui – Germany, Oman, 2019-03-13 19:35  – Posting: # 20030
Views: 470

Dear Ohlbe,

» 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.

Such multiple clinical trial centers ( for one drug product), you might find them in different cities, ( you could find them even in different countries depending on the presence of the patients for a certain disease, therefore we will not be able to talk about a central lab, which uses the same technology.

I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.

Best regards,
Osama

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,437 posts in 4,125 threads, 1,325 registered users;
online 8 (1 registered, 7 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 02:15 CEST

On two occasions I have been asked,—“Pray, Mr. Babbage,
if you put into the machine wrong figures,…
will the right answers come out?”

I am not able rightly to apprehend the kind of confusion of ideas
that could provoke such a question.    Charles Babbage

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5