reportable value the value that will be compared to an acceptance criterion. [note—1. the acceptance criterion for comparison may be in the usp monograph, or it may be set by the company, e.g., for product release. 2. the term reportable value is inextricably linked to the “intended ...
In addition, assay, run, and sample acceptance criteria such as system suitability and similarity should be specified before performing the validation. Depending on the extent of development of the bioassay, these may be proposed as tentative and can be updated with data from the validation. Assay...
Methodology Used to Define Equivalence Limits:As described by Hauck et al., approach A described in USP<1032> — tolerance interval derived from historical values of nonparallelism — is the simpler approach to determine equivalence limits, and it ...
More specifically, certain embodiments of assay methods were tested and found the meet the following acceptance criteria: The overall agreement rate between valid sample results and the expected results shall be 95.0% or greater. HBV-negative samples should have PCR-negative results, and HBV-positive...
Sample Preparation Extract the genomic DNA from patient specimens as soon as possible. Resuspend DNA to a final concentration of 100 µg to 400 µg per mL in 1/10th TE (1 mM Tris-HCl, pH 8.0; 0.1 mM EDTA) or in molecular biology grade or USP water. This is a robust assay ...
It should be noted at this point that different LAL suppliers have different acceptance criteria for the LAL test and calculate their %CVs, through software packages, in different ways. Some, for example, calculate the CV based on the results of obtained in Endotoxin Units per millilitr...
Precision (%RSD) with acceptance criteria of ±15% for all QC except for LLOQ being allotted a ±20 %RSD. %RSD was calculated as described in Equation (1). Accuracy (%Bias) with the same acceptance criteria as precision. %Bias was calculated as described in Equation (2). %𝑅𝑆...
For the quantification of insulin activity, United States Pharmacopeia (USP) general chapter <121> continues to require the rabbit blood sugar test. For new insulin or insulin analogue compounds, those quantitative data are expected for stability or comp