Pharmaceutical Application of Bioanalytical Method Validation (BMV)

The bioanalytical method commonly called as BMV is a set of sequential procedures that are involved in the following:  collection, processing, storage and analysis of a biological matrix of a chemical compound. Bioanalytical method validation process is used to establish the quantitative analytical method that is suitable for the biomedical applications.

BMV includes certain procedures that have the ability to demonstrate a particular method used for quantitative measurement of analytes in a given biological matrix is reliable and reproducible for intended use. BMV is important not only in terms of regulatory submission but also for ensuring the generation of high-quality data during the drug discovery and development.

BMV assure that the quantification of an analyte in the biological fluids is reliable, reproducible and suitable for the application.

Why Validate Bioanalytical Methods?

The main reason for validating a bioanalytical method is to demonstrate the reliability and performance of a specific method and the assurance that can be placed on the results of a method. All bioanalaytical methods need to be validated if the same results are used to support the registration of a new drug or reformulation of an existing drug.

What is the Need of BMV?

The following reasons indicate why there is a need for bioanalytical method validation (BMV):

  • To yield reliable results, it is essential to make use of well characterized and completely validates bioanalytical method.
  • Constant changes and improvements in the BMV takes place and they are at the cutting edge of the technology
  • A specific validation criterion is required for each analyte because each bioanalytical technique has its own characteristics and it may vary from analyte to analyte.

Types of BMV

There are three types of BMV:

  1. Full validation

Full validation is important in the following conditions:

  • While developing and implementing a bioanalytical method for the first time
  • For a new drug entity
  • When the metabolites are added to an existing assay for quantification.
  1. Partial validation

Partial validation is that modification of already validated bioanalytical methods that does not require a full validation. Partial validation is required for:

  • Bioanalytical method transfers between the analysts or laboratories
  • Change in the matrix within the species
  • Change in sample processing procedures
  • Change in relevant concentration range
  • Changes in software platforms
  • Changes in the instruments
  • Changes in analytical methodology
  1. Cross validation

The comparison of validation parameters when more than one bioanalytical method is used to generate data, cross validation is required.

BMV and Drug Development

Highly sensitive methods are required in today’s drug development environment, to quantify drugs in matrices. Chromatographic methods are the most commonly used methods for the bioanalysis of small molecules.

As per the detailed review, BMV application plays a major role in the pharmaceutical industry.


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