What’s the Purpose of the latest FDA Guidance for Method Development and Validation?


Bioanalytical method development and validation protocol is the basis for establishing quantitation of the pharmaceutical drug candidate and their supporting metabolites within the biological matrix. This is accomplished in a systematic array of protocols, including collection, storage, preparation of the sample, separation of the active components, identification, and final quantification. Bioanalytical method development is responsible for the analyte identification, removal, determination of the analyte concentration, preconcentration, dissolution, and final quantification.

Why is it important to perform validation of the newly developed bioanalytical method?

The reasons associated with the bioanalytical method development and validation protocol is the determination of both the performance and reliability of the concerned method. Additionally, all the supporting bioanalytical methods should be precisely validated if the results derived from them would supplement the registration of a new pharmaceutical drug candidate. It also finds greater applicability in the process of reformulating the existing pharmaceutical drug candidate. Bioanalytical method development and validation involve documentation throughout the different laboratory investigational processes for ensuring that the bioanalytical method has been thoroughly validated. Furthermore, it ensures that the evaluated performance characteristics of the bioanalytical method being developed are both suitable and reliable for its intended and defined bioanalytical testing.

Why is there a need to accomplish bioanalytical method validation?

A validated bioanalytical method has become a pre-requisite today both for yielding well-characterized and reliable results for achieving satisfactory interpretation of the bioanalytical process.

Over time, it has been established that the various bioanalytical methods and protocols continuously undergo changes and improvements. As they represent the cutting-edge technology for the pharmaceutical sector, clinical analysts need to be up-to-date with the latest advancements in the industry.

It is essential to understand that the bioanalytical methods and techniques have their own set of defining characteristics. These characteristics vary widely from one analyte to another analyte according to the specific validation criteria.

 The essential bioanalytical validation parameters –

The parameters designed for the validation of the bioanalytical testing are as follows –

Selectivity –

Selectivity is the ability of any bioanalytical method to establish differentiation and quantify the analyte of interest in the presence of other interfering components.

Accuracy –

The accuracy of the bioanalytical method depends on the closeness of its determined value with the actual value.

Precision –

Precision indicates the relative closeness of the replicate determinations of an analyte sample with the help of a bioassay. Precision is a decisive factor comprising of repeatability, intermediate precision, and reproducibility of the analytical characterization.

Recovery –

Recovery characterizes the extraction efficiency of a bioanalytical method to fall within its limits of variability.

Stability –

The stability of an analyte of interest within a given biological matrix under specific testing conditions over definite time intervals helps define the chemical stability of the pharmaceutical drug candidate.

Advantages of the bioanalytical method development and validation –

The following are the advantages of accomplishing bioanalytical method development and validation process –

It helps in building a certain degree of confidence both for the method developer and the final user.

The bioanalytical method exercise is inexpensive as it helps eliminate the frustration repetitions, thereby leading to better management of the time invested.

The validation step of the bioanalytical method involves absorbing shock variations of all the conditions of bioanalysis.


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