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FDA Bioanalytical
Bioanalytical method development is a process of defining the design, operating conditions, limitations, and applicability of a given bioanalytical protocol for its intended purpose. A blend of all this ensures whether a method is optimum to be validated for its large- scale use.
Before developing any bioanalytical method, the applicant should evidently focus on understanding analyte chemistry. This involves gaining sufficient knowledge about the physicochemical properties of the test pharmaceutical product under analysis, both in vitro and in vivo drug metabolism, and the characteristics of protein binding. It further considers all the concerned aspects of any prior bioanalytical method if at all applicable.
The development of any bioanalytical method involves optimizing both the procedure and condition for performing bioanalysis on the given pharmaceutical drug candidate. The process of method development involves optimizing the following set of bioanalytical parameters to ensure its eligibility for qualifying the ICH method validation process –
- Critical reagents
- Reference standards
- Calibration curve
- Quality control samples
- Selectivity and specificity
- Accuracy
- Precision
- Sensitivity
- Recovery
- Analyte stability
- Minimum required dilution
The bioanalytical method development process does not require a large piece of record maintenance and notation. Once the bioanalytical method has been developed, it becomes essential for the method to be optimized so that it becomes suitable for analyzing the study sample.
Types of Bioanalytical Method Validation –
Full Validation –
Bioanalytical method validation is an essential parameter for ensuring the acceptability of both the assay performance and assessment of how reliable and accountable the bioanalytical results are. Here, you have a different set of protocols focused on the measurement of the concentrations of your analytes of interest within a given biological matrix. This method is routinely performed for the analyte quantification in both the pivotal clinical and clinical studies.
Cross-Validation –
The bioanalytical method validation studies are those where you derive data from different sources either within or across the studies. One additional way in which this bioanalytical method is accomplished is by obtaining the relevant piece of bioanalytical data from different laboratories located at different locations employing the same method. It is a pre-requisite to establish a comparison between the data derived from different laboratories and a cross-validation report for the same is generated.
Partial validation –
Partial bioanalytical method validation is essential when you have to evaluate the modifications introduced to the full bioanalytical validation protocols. Partial validation ranges from the determination of the low accuracy and precision until complete method validation. The items under partial validation are determined by their extent and nature of the changes introduced to the original method.
Parameters of Bioanalytical Method Validation –
The parameters mentioned under bioanalytical method validation protocol are –
Selectivity –
It is the ability of a bioanalytical method for differentiating and measuring the analyte concentration in the presence of all the potential interfering substances present within the blank biological matrix.
Specificity –
Specificity helps the clinical bio-analyst in establishing the detection and differentiation method for determining the analyte concentration in the presence of other interfering substances.
Matrix Effect –
A matrix effect is defined as any alteration introduced to the response produced by the analyte due to the presence of interfering and unidentified components within the biological matrix.
Accuracy and Precision –
The bioanalytical method evaluation parameters of accuracy and precision should be evaluated by analyzing the quality of the pharmaceutical drug candidate within each run and across different runs.
