Guide To Preparing Quality Analytical Testing

Bioanalytical technology development and the final applications of the pharmacokinetic principles are responsible for the creation of a synergistic partnership. This partnership contributes to its influential and vital role in the discovery and development process of new pharmaceutical entities. Lead optimization or selection, product characteristics confirmation, and the process of testing those pharmaceuticals work as a series of activities for the synthesis of new drug formulation. The analytical testing priorities of pharmaceutical industries are – fast pass or fail determination of the pharmacokinetic parameters, an assay of medium sensitivity, minimum assay development, and high specificity and throughput for all the compounds of relevance.

Challenges involved in the development of the methods for analytical testing –

The following factors play a lead role in developing any bioanalytical method of interest –

Number of samples –

Both the number of samples and the number of analyses provide accurate information for determining the suitability of a process for clinical trials.

Urgency –

The bioanalytical methods should be defined carefully, which requires a relatively short turnaround time, and all the relevant analytical speed is appropriately balanced against other analytical considerations. Here, the automated processes can play a chief role.

Matrix used –

The matrix preferred by most of the analytical laboratory services is inclusive of serum, plasma, tissue, and urine. Every matrix possesses different implications regarding the sample interference and cleaning up of the matrix.

Pharmacokinetic profile of the targeted analyte –

It is relatively significant to understand the pharmacokinetic profile for determining the lower quantization levels for every single pharmaceutical drug candidate under analysis.

Bioanalytical testing parameters –

There are specific parameters which are usually considered for optimization before validating a particular analytical testing protocol.

Reference standards –

The sponsor of the clinical trial should appropriately characterize and document all the relevant reference standards and critical reagents being used in the process.

Calibration curve –

While developing an analytical testing method, the analytical testing service should define the assay quantitation range and standard calibration concentration based on the concentration range, which you expect out of your study.

Quality Control Samples –

Quality control protocols are essential for assessing and defining both the precision and accuracy of a particular bioanalytical testing procedure as well as determining the stability of the sample under analysis.

Selectivity and Specificity –

Both selectivity and specificity indicate that the intended analyte can minimize or avoid interference produced by the matrix being used in its preparation.

Sensitivity –

LLOQ helps in defining the sensitivity of the analytical testing method and is usually determined during the process of method development.

Accuracy, Precision, and Recovery –

Evaluation of both the accuracy and precision of the analytical testing across its quantitation range throughout the method development process is essential. It helps in deriving on a conclusion whether the developed method is ready for validation or not and is inclusive of replicate quality controls at different concentrations across the range of the assay.  

Validation of analytical testing protocols –

Once the developed bioanalytical assay has been optimized both for throughput and sensitivity determination, it is important to validate it. The US Food and Drug Administration has a pre-set guideline documented for accomplishing this task. The analytical testing services can refer to their instructions for validating their developed assays.

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Maria Brown Joined: April 1st, 2020