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Greetings to every member
Dear members, will you clarify my doubts on the Repeats analysis.
1. Is the criteria for the maximum number of Repeats for a run
and / or total number of samples for the study, for the US-FDA
submission studies, If so, please inform. Is there any difference of
this criterian for pilot / pivotal / submission studies?
2. If thee is difference of 18 % between the first observed value
and the average value of two repeats( sample is insufficient for
thrid replicate), then what value should be taken for analysis.
3. In the CC curve, apart from lowest and highest, shall we delete
two consecutive points in the eight point calibratio curve? Please
inform this also.
Thanking you in advance and regards to everybody,
T.R. Yegnaraman
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The following message was posted to: PharmPK
Hello,
I have an additional question regarding repeat analysis. I am in the
process of creating a document which clarifies the rationale for the
procedure which outlines the reassay criteria for Sponsor requested
reassays requiring repeat analysis. I would really appreciate any
feedback as to the criteria that is used at other companies when
requesting reanalysis of data.
Thank you,
S.Reid
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It is reasonable to repeat samples on the grounds of being
"pharmacokinetic
outliers": you need to have an SOP in place
prior to performing any assays. The SOP will define "pharmacokinetic
outliers" and the procedure for handling repeats including assay value
acceptance and rejection criteria by the source laboratory.
Please see page 18 of the guideline below (Topic: Repeat Analysis)
The FDA guidelines on Bioanalytical Methods
(http://www.fda.gov/cder/guidance/4252fnl.htm)
Hopefully, this will serve your purpose.
Regard
Mitesh Gandhi
BioArc Research Solutions
Vadodara
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