shahajan baig

2020-07-06 01:15
(770 d 06:41 ago)

Posting: # 21651
Views: 1,560

 Missing concentration [Study As­sess­ment]

Hello everyone,

I have one question with respect to missing sample concentration consider:

Case study:
  • One subject sample analysis for PK study did not shown any concentration in both the periods.
  • Dosing was done as per protocol compliance and same was monitored by CRO QA, QC and sponsor monitor and have documented for compliance done.
  • What could be a point of investigation for the above case???? :-|

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


Sukalpa Biswas

2020-07-13 13:51
(762 d 18:05 ago)

@ shahajan baig
Posting: # 21682
Views: 975

 Missing concentration

» – What could be a point of investigation for the above case???? :-|

The investigation can be done clinically or bioanalytically.

Clinically, the after dosing activities, restrictions can be traced very closely by camera evidences. Any suspected activity need to be investigated/evaluated. One to one meeting with subject could be a part of clinical investigation.

Bioanalytically, the particular subject can be repeated with proper justification and documentation. Method, chromatographic and mass parameter must be checked for that particular batch. Hope samples from that subject included in ISR. ISR/Repeat data one of the conclusive evidences.

If still inconclusive, then can be done re dosing study depending upon consultation with the regulatory you are targeting for (if regulatory allows).
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