Reinjection Reproducibility (RR) [Bioanalytics]

posted by ksreekanth – India, 2020-07-01 18:49 (120 d 20:27 ago) – Posting: # 21633
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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.

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