Matrix effect during study sample analysis [Bioanalytics]

posted by shreyas goswami  – India, 2020-04-09 08:18 (199 d 15:49 ago) – Posting: # 21320
Views: 2,790

No matrix effect observed during method development and method validation but what if matrix effect observed during subject sample analysis. ISTD {labelled IS} response difference in subject sample and CC/QC sample is found more than 40 percent. Moreover CC/QC samples were interspersed with subject samples and entire batch was processed in single processing batch.

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:

Looking for members opinion.


Edit: Category changed; see also this post #1 [Ohlbe]

Complete thread:

 Admin contact
21,179 posts in 4,414 threads, 1,475 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 23:07 CET (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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