DMPK Bioanalysis

LOD, LLOQ, and ULOQ are important parameters for ensuring the reliability of bioanalytical results, defined as follows:

LOD (Limit of Detection) refers to the lowest amount or concentration of analytes that can be reliably detected under certain analysis conditions but not necessarily for accurate quantification.

LLOQ (Lower Limit of Quantification) is the lowest concentration of analyte in a sample that can be reliably quantified with acceptable accuracy. The LLOQ is the lowest concentration point of the standard curve and should be suitable for the anticipated concentration and experiment purpose.

ULOQ (Upper Limit of Quantification) is the highest concentration of analyte in a sample that can be reliably quantified with acceptable accuracy under given analysis conditions and methods. The ULOQ is the highest concentration point of the standard curve and should be suitable for the anticipated concentration and experiment purpose.

Method validation is a series of tests and evaluations to demonstrate the reliability of a specific analytical method in determining the concentration of an analyte in a certain biological matrix, aiming to prove that the adopted bioanalytical method is suitable for the intended purpose. Generally, the complete method validation of a chromatographic analysis should include selectivity, specificity, matrix effect, calibration curve (response function), range (from LLOQ to ULOQ), accuracy, precision, carryover, dilution linearity, stability, and reproducibility of sample re-injection, etc.

The advantage of Non-GLP bioanalysis is that it provides greater flexibility, allowing researchers to make necessary optimizations and adjustments during the experiment. Additionally, its relatively lower cost increases the cost-effectiveness of the research. Most importantly, Non-GLP bioanalysis can obtain experimental data quickly with a shorter turnaround time, thereby accelerating the research process.