ksreekanth
☆    

India,
2020-07-01 18:49
(118 d 19:03 ago)

Posting: # 21633
Views: 1,680
 

 Reinjection Reproducibility (RR) [Bioanalytics]

Hi i need clarity regarding Reinjection Reproducibility (RR) experiment which is performed during Bioanalytical method validation. I have observed two kinds of approaches which one to choose:

Approach 1.
RR with initial CC and RR with reinjected CC:

In this approach once run got acquired and accepted, same run (with same set of CC standards as well low and high level QC samples) will be reinjected and considered as RR with reinjected CCs. and further this reinjected low and high level QC samples results will be compared with initial run CC and accuracy of QCs will be checked as RR with Initial CC. Here reproducibility of the accuracy data of QC samples (Unknown study samples) with initial CC as well as Reinjected CC is demonstrated which is the primary check point and however stability is comparable.

Approach 2.
RR with fresh CC:

In this approach once run got acquired and accepted, only the low and high level QC samples of this run will be reinjected under fresh CC standards and checked for accuracy and said that reinjection stability is established.

Kindly clarify whether the check point is reproducibility of QC results with Initial CC as well as reinjected CC (Approach 1) or the stability of reinjected QC samples under fresh CC (Approach 2). Which approach to be followed and established during method validation so as to mimic reinjection conditions due to system stoppages encountered during study sample analysis.
Ohlbe
★★★

France,
2020-07-02 18:35
(117 d 19:16 ago)

@ ksreekanth
Posting: # 21638
Views: 1,073
 

 Reinjection Reproducibility (RR)

Dear ksreekanth,

» Hi i need clarity regarding Reinjection Reproducibility (RR) experiment which is performed during Bioanalytical method validation. I have observed two kinds of approaches [...]
» Kindly clarify whether the check point is reproducibility of QC results with Initial CC as well as reinjected CC (Approach 1) or the stability of reinjected QC samples under fresh CC (Approach 2). Which approach to be followed and established during method validation so as to mimic reinjection conditions due to system stoppages encountered during study sample analysis.

Well, what do you plan to do if you have to re-inject part of the samples during your study because of an instrument failure in the middle of the run: will you refer to the initial calibration curve (Approach 1), or prepare a fresh calibration curve and analyse the old samples against a fresh curve (Approach 2) ?

So how do you think you should proceed during your validation ?

Regards
Ohlbe
ksreekanth
☆    

India,
2020-07-02 18:48
(117 d 19:04 ago)

@ Ohlbe
Posting: # 21639
Views: 1,073
 

 Reinjection Reproducibility (RR)

» So how do you think you should proceed during your validation ?

Approach 1 to be followed.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Please follow the Forum’s Policy! [Helmut]
xtianbadillo
☆    

Mexico,
2020-07-03 03:25
(117 d 10:26 ago)

@ ksreekanth
Posting: # 21640
Views: 1,040
 

 Reinjection Reproducibility (RR)

Approach 2. “The QC samples are analysed against a calibration curve, obtained from freshly spiked calibration standards, and the obtained concentrations are compared to the nominal concentrations. The mean concentration at each level should be within ±15% of the nominal concentration.” (EMA validaton guidelines "Re-injection of samples can be made in case of instrument failure if reinjection reproducibility and oninjector stability have been demonstrated during validation")


Approach 2. Its equivalent to oninjector stability. So a different approach should be considered.

Approach 1. You can consider an anova with different injections at different times. or, check bias and precision between injections at diferrent times.
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