Matrix effect during study sample analysis [Bioanalytics]

posted by Ohlbe – France, 2020-04-09 14:57 (122 d 01:13 ago) – Posting: # 21324
Views: 813

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

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