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Hi,
Are any of the regulatory guidelines mentioning about the acceptance
criteria for the number of blank plasma lots to be with in the
specifications (out of at least 6 lots) for a particular
bioanalytical method.
For example during the validation, we have screened 6 blank plasma
lots and out of which 4 were with in the specifications (20% of LOQ
and 5 % of IS area) for the interference at the RT of analyte and IS,
Shall we consider the screening as pass, or do we need to have all
the plasma lots which are screened to be with out any significant
interference or
Do we need to have any acceptance criteria like 66%, 80% or 100% of
the lots screened should be with out any significant interference,
since we do not have any acceptance criteria in our SOP.?
Please provide the expert opinion.
Regards
Debbie.
Back to the Top
Hi,
Are any of the regulatory guidelines mentioning about the acceptance
criteria for the number of blank plasma lots to be with in the
specifications (out of at least 6 lots) for a particular
bioanalytical method.
For example during the validation, we have screened 6 blank plasma
lots and out of which 4 were with in the specifications (20% of LOQ
and 5 % of IS area) for the interference at the RT of analyte and IS,
Shall we consider the screening as pass, or do we need to have all
the plasma lots which are screened to be with out any significant
interference or
Do we need to have any acceptance criteria like 66%, 80% or 100% of
the lots screened should be with out any significant interference,
since we do not have any acceptance criteria in our SOP?
Please provide the expert opinion.
Regards
Debbie.
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The following message was posted to: PharmPK
Most require that at least 80% (5 of 6)of unspiked samples must return
values less than the LLOQ and at least 80% of samples spiked at the LLOQ
must return values within +/- 15% (20%) of the LLOQ. There may be
additional requirements at the ULOQ as well
--
Ed O'Connor, Ph.D.
Laboratory Director
Matrix BioAnalytical Laboratories
25 Science Park at Yale
New Haven, CT 06511
Web: www.matrixbioanalytical.com
Email: eoconnor.-a-.matrixbioanalytical.com
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