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Hello Forum,
Could some one tell me,
under what conditions reanalysis, repeat analysis of samples is
permitted in bioequivalence studies.
or tell me which guidence refers to it.
Nisha. K. R.
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The following message was posted to: PharmPK
Hi Nisha,
Please find some acceptable reasons for repeat
analysis. To do repeat analysis and also to accept
repeat analysis values you have to have SOPs and
decision trees and who are involved in repeated
analysis.
If any sample is not sufficient for repeat analysis
you should have documented it well before actual
analysis begins depending upon the volume required for
analysis.
1) Poor or bad chromatography
2) Calibration curve or QC samples of a batch meeting
acceptance criteria
3) Instrument (pump, detector, column etc.) failure
4) Subject sample conc. outside the CC range
5) Unacceptable internal standard response/ area
6) Sample processing/dilution error
7) Inconsistent pharmacokinetic data
8) Re assay requested by sponsor
9) Retention time variation
10) Inconsistent replicate analysis
11) Concentration observed in pre dose sample(s)
12) very rarely failure to acquire the data by the
software.
I hope this information will be helpful and it will be
great if anybody add some inputs to above points.
regards,
nageshwar.
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