Matrix effect during study sample analysis [Bioanalytics]

posted by Ohlbe – France, 2020-04-09 14:57 (555 d 17:23 ago) – Posting: # 21324
Views: 1,462

Dear Shreyas,

» Do we need to conduct further analysis with proper investigation and what if matrix effect observed due to change in population matrix.
»
» Does this data accepted by regulatory agencies.:confused:

Have a look at this special issue of Bioanalysis. There are papers from folks from the FDA, MHRA, ANSM and ANVISA, which can give you some ideas on the reactions of regulators, and papers from industry which can give you some ideas on what to do.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time: Sunday 08:20 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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