shreyas goswami
☆    

India,
2020-04-09 08:18
(199 d 15:55 ago)

Posting: # 21320
Views: 2,792
 

 Matrix effect during study sample analysis [Bioanalytics]

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.

Thanks.:-)


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

Belgium?,
2020-04-09 08:40
(199 d 15:32 ago)

@ shreyas goswami
Posting: # 21321
Views: 1,086
 

 Matrix effect during study sample analysis

Hello shreyas goswami,


» 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.

A trillion billion years ago, when companies used to buy citrate plasma from blood banks to use for QCs and calibrators, while they were using Heparin or K2EDTA tubes etc for the PK samples, this effect was seen. It could go in both directions (enhancement, suppression). I believe companies learned that regulators were not, to say the least, supporting that practice with much enthusiasm :-D

» Do we need to conduct further analysis with proper investigation and what if matrix effect observed due to change in population matrix.

There are no clear rules stated anywhere what to do, but it sounds like your QC + calibrator matrix has some properties that differ from that of your samples, and some degree of investigation would be a good idea.
Can you show the data or an IS plot?

» Does this data accepted by regulatory agencies.:confused:

If they notice it then they are in their good right to raise a lot of questions. And they might do so.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
shreyas goswami
☆    

India,
2020-04-09 12:27
(199 d 11:45 ago)

@ ElMaestro
Posting: # 21322
Views: 1,072
 

 Matrix effect during study sample analysis

»Thank you Dear ElMaestro for your precious quick reply.

I dont have IS plot here due to restricted data access with other devises at home due to nationwide lockdown.

Will post IS plot soon.

Thank You Again:-)
Ohlbe
★★★

France,
2020-04-09 14:57
(199 d 09:16 ago)

@ shreyas goswami
Posting: # 21324
Views: 1,045
 

 Matrix effect during study sample analysis

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
shreyas goswami
☆    

India,
2020-04-10 17:29
(198 d 06:43 ago)

@ Ohlbe
Posting: # 21329
Views: 1,031
 

 Matrix effect during study sample analysis

» 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.


Thank you Dear Ohlbe for such a important content. This will definitely help me out.
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