ich method validation

How Does ICH Guidance Compare To FDA Bioanalytical Method Validation?

The ICH method validation guidelines provide recommendations for quantification and application of bioanalytical assays, both for the chemical and biological drug products. Bioanalytical method development and validation are essential for defining the designing and operating conditions, determining the limitations as well as the suitability of the developed bioanalytical methods.

Before developing any bioanalytical CRO method, the applicant needs to understand the analyte of his interest. The process of bioanalytical method development involves the optimization of both the process and conditions for extracting and detecting the analyte under consideration.

Th essential parameters for ICH method validation –

The following parameters define the success of the bioanalytical method validation –

Choice of the reference standards –

While validating a bioanalytical method, you need to consider the reference standard according to its characterization, identity, strength, and purity. The reference standard is used in the ICH method validation process. It should be obtained from an authentic and traceable source.

Selectivity –

Selectivity is the ability of a bioanalytical method for differentiating and measuring the analyte in the presence of other interfering substances. The selectivity of a given analyte of interest is usually detected in a blank biological matrix.

Specificity –

Specificity is used for determining the ability of a bioanalytical method for detecting and differentiating the analyte of interest from other substances, including those which relate closely to them.

Matrix Effect –

A matrix effect is an alteration of the response produced by an analyte due to interference generated by the presence of an unidentified compound in the sample matrix.

Calibration Curve –

The calibration curve establishes the relationship between the nominal concentration of the analyte and the response generated by the analytical platform in its response.

Stability –

The evaluations of the developed bioanalytical method’s stability should be accomplished to ensure that every step involved in the process of sample preparation, analysis, and processing and during storage do not alter the analyte concentration.

Reinjection Reproducibility –

The reproducibility of the developed bioanalytical method is assessed by replicating the measurements of the QCs. This step is important for the determination of the precision and accuracy of the bioanalytical method.

Why is ICH method validation important?

Bioanalytical method validation ensures the acceptability of the bioassay’s performance range and how reliant it is in producing reproducible analytical results. This method includes a set of bioanalytical procedures for determining the concentration of an analyte in the given biological sample. It is essential to accomplish bioanalytical method validation while subjecting the method developed to clinical and pivotal clinical assessments.

FDA bioanalytical method validation has two principal types –

Partial Validation –

A fully validated analytical method can be modified by evaluating it with the help of a partial validation procedure.

Cross-Validation –

Data derived from different bioanalytical methods within or across the studies establishes a robust comparison. It compares the derived data to  cross-validation of the applied bioanalytical techniques.

Remember, full validation of the bioanalytical process is necessary when the developed method has a literature backup. The commercial kit available can be subjected to re-purpose its use in bioanalytical drug development.

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