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I am involved in developing PK method for therapeutic mabs for both
preclinical and clinical studies. Usually we spike the drug in neat
matrix for making both calibrators and QCS , followed by the minimum
required dilution. Recently we came across a CRO who makes the
calibrators in minimally diluted serum, but makes the QCs in neat
serum, followed by MRD. I would deeply appreciate if you could share
your way of doing this.
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Can we examine the use of the term minimum required dilution. It makes
no sense. It is part of the assay.
The processing is part of the assay and there can be no other way of
processing the samples. This is a point in the confusion.
Samples exceeding the ULOQ of the assay may be diluted with screened
negative matrix to fit within the curve. Ultra high QC should be
processed as a check of the recovery for diluted samples.
What is minimally diluted matrix????
1) QCs and calibrators should be prepared in the same matrix as the
2) QC should be stored and processed with samples in the same manner
that samples are processed.
To the extent that the preparation, processing and storage of Cals and
QCs differ from that of the samples they are neither. There are
exceptions (rare matrices) but your description does not match that.
3) To the extent that the CRO is willing to jeopardize your samples
(and it sound like they are), you should be willing to change CROs and
find one that knows what they are doing!
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