Development and validation of analytical methods
The Bioanalytical and Molecular Biology units also perform activities of development and validation of suitable and reproducible analytical methods for the execution of experimental studies, and ensure that the methods used to analyze the samples are accurate, precise, reproducible, and robust. The process of developing an analytical method starts from the accurate knowledge of the analyte (nature, biological matrices in which to analyze it and expected concentration) and of the regulatory standards and guidelines, such as those established by the ICH; then the process includes the choice of the technique to be used by optimizing the protocols, and the final step is the execution of preliminary analyses in order to collect initial data and make changes to the method, if necessary.
Validation is the process through which it is demonstrated that the developed analytical method is fit for purpose.
Validation ensures that the analytical method is appropriate for the intended use, an essential requirement to guarantee the quality and safety of products, particularly in regulated sectors. This process guarantees the validity of the results obtained and ensures that they can be replicated in other laboratories under the same operating conditions.
The main parameters considered in a validation protocol are:
- Accuracy
- Precision
- Specificity and Selectivity
- Linearity
- Robustness
- Stability
- Recovery.