Method Man II
Before sample extraction begins, samples should be thawed in this environment
What is an ice bath?
This QC is used only during validation
What is the LLOQ QC?
This code is used when the wrong expiration date was written and corrected
What is RE (Recording Error)?
The minimum number of individual matrix sources evaluated for selectivity
What is six individual, non-pooled sources?
This is the primary objective of bioanalytical method validation
What is to demonstrate that the method is suitable for its intended purpose?
The acceptable retention time range during system suitability
What is 3.00 to 4.00 minutes?
The DQC is prepared from this concentrated solution
What is the 2,000,000 ng/mL stock solution?
No pages may be removed from this type of notebook
What is a bound notebook?
The maximum allowable IS response in a selectivity blank
What is ≤5% of the average IS response at LLOQ?
A chromatographic calibration curve must contain at least this many concentration levels
What is six concentration levels?
The analyte transition monitored for BMS-986278
What is m/z 444.3 → 273.9?
This QC serves as the source solution used to prepare the HQC
What is the 8,000 ng/mL DQC?
If original laboratory records are lost and cannot be reproduced, the resulting study data are considered this
What are unreliable and must be rejected and repeated?
This is what happens if the calibration curve is rejected
What is the entire run must be rejected and reanalyzed?
This is the minimum number of analytical runs required for accuracy and precision validation
What is three runs?
The software used for quantitative data reduction
What is Watson LIMS v7.6.1?
If the DQC were prepared incorrectly, this higher-level QC would also be affected
What is the HQC (800 ng/mL)?
In IDBS, completion of sample-processing steps should generally be documented within this timeframe
What is within 30 minutes of completion of the step?
The minimum number of freeze-thaw cycles that must be evaluated
What is three cycles?
Samples should remain frozen at least this long between freeze-thaw cycles
What is 12 hours?
A 1 mL plate may be used, but this size is preferred
What is a 2 mL 96-well collection plate?
An analyst accidentally used 0.200 mL of stock instead of 0.0200 mL when making the DQC. The DQC concentration would be approximately this much higher
What is 10 times higher than intended?
How we know a notebook page is complete
What is the signed/initialed signature block and lined-out unused space?
Calibration standards and QC samples should normally be prepared from these
What are separate stock solutions?
For chromatographic methods, at least this percentage of ISR results must agree within ±20%
What is two-thirds (2/3)?