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Debbie ★ India, 2014-07-11 17:16 (3971 d 06:42 ago) Posting: # 13261 Views: 3,777 |
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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. |
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Debbie ★ India, 2014-07-24 10:28 (3958 d 13:29 ago) @ Debbie Posting: # 13305 Views: 2,800 |
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Hi, Kindly provide the opinion about the matrix stability evaluation during bioanalytical method validation for the following instance. 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 |
Ing. Helmut Schütz