Important Key Facts about Bioanalytical Method Validation during Drug Development

Bioanalytical method validation is the process of validating a method that would be used to test a drug component. This ensures that the models or assays are capable of producing relevant results that will be used to carry forward the drug development procedure. 

In assay development, multiple parameters are taken into account. Without these, the drug test would be incomplete. These parameters establish the fundamental criteria which a new drug component must fulfill to be considered.

What Are The Bioanalytical Method Validation Parameters From FDA?

There are around eleven parameters which, according to the FDA, bioanalytical method validation procedures must live up to. Noteworthy ones include the following:

Specificity/Selectivity Of The Methods

This is the factor that judges if the method is efficient enough to detect the desired metabolite in the presence of several other expected components. To ensure that the technique does so, it should bear positive results when the analyte is present in a sample and indicate its absence when the desired analyte is not found in a sample.


This is the factor that judges the analyte in a minimum of three different concentration levels, to check how useful the adopted assay is.


According to the FDA, bioanalytical method validation must comprise of recovery experiments in three different concentrations i.e., low, medium, and high.


At least five determinations per concentration are expected to check the precision of bioanalytical methods.

These are just some guidelines that form the basis of bioanalytical method validation, as laid out by the FDA. Apart from these several factors of stability, reproducibility and calibration curve are also taken into account while validating bioanalytical methods.

Documenting The Established Methods

In all forms of assay development, it is necessary to properly document all reports received and data generated through the process. This is known as a practice termed as documentation for method establishment.

It comprises a lot of reports that play a vital role in the initial stages of drug development. These reports include operational description, evidence for identifying drug standards, internal standards, and more.

Use Of The Method In Routine Drug Analysis

In a routine analysis of drug development or discovery, the validated methods play an essential role. This takes into account all samples of the analyte in several matrices like plasma, blood, et cetera. Various tests like system sustainability, response function, and repeat analysis are considered in this type of application.

FDA Encouragement For Assay Development

While the FDA does layout multiple guidelines for assay development, it also has its restrictions for using different bioanalytical methods for the same drug. As one set of methods use specific platforms for testing samples that vary from others, the FDA suggests that the data from the second method must bridge with the first. 

A minimum of 20 samples from each of these would be able to provide a satisfactory result.

Bioanalytical methods have their own set of restrictions and limitations when it comes to the FDA. These parameters set the standard for research in drug development.

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