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RegisterNumber of samples for Matrix Stability [Bioanalytics]
Hi,
As per US FDA Bioanalytical Method Validation (BMV) guidance (My 2001 and Sep 2013 draft) at least three aliquots at each of the Low QC and High QC should be used for stress testing for Freeze-Thaw, Bench-Top and Long Term Stability evaluations.
Is it acceptable to use only one sample tube (containing sample volume for three aliquots) for stress testing of above stabilities and later during analysis, the sample will be processed in triplicate.
Is there any statistical requirement to use at least three samples for stress testing?
Regards,
Debbie.
As per US FDA Bioanalytical Method Validation (BMV) guidance (My 2001 and Sep 2013 draft) at least three aliquots at each of the Low QC and High QC should be used for stress testing for Freeze-Thaw, Bench-Top and Long Term Stability evaluations.
Is it acceptable to use only one sample tube (containing sample volume for three aliquots) for stress testing of above stabilities and later during analysis, the sample will be processed in triplicate.
Is there any statistical requirement to use at least three samples for stress testing?
Regards,
Debbie.
Complete thread:
- Number of samples for Matrix StabilityDebbie 2014-07-11 15:16
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- Number of samples for Matrix Stability Debbie 2014-07-24 08:28
Ing. Helmut Schütz