One of the most important challenges faced by the pharmaceutical industry today is looking for innovative and integrated ways to:
increase their productivity,
cut down cost
develop new remedies that improve human health
To help take in hand these setbacks, the employment and utilization of analytical technologies and high-output automated platforms has been incorporated; to conduct more experiments in shorter time frames with increased data quality.
The Food and Drug Administration (FDA) formulates the final guidance for industries. The latest scientific feedback is given regarding bioanalytical methods. It also provides the most advanced information needed by drug developers to make sure of the bioanalytical quality of their figures. Therefore, the purpose of FDA Bioanalytical Method development is to label the design, the limitations, and the suitability of the method. It also states guidelines to manage operating conditions for its proposed purpose and to make certain that the method is optimized for validation.
Before the development and execution of any particular Bioanalytical method, the sponsor should recognize the analyte of interest. For instance, determining the physicochemical properties of a drug product and its in-vitro and in-vivo metabolism, along with protein binding) and consider every facet of any prior analytical methods that might be applicable.
Method development entails the optimization of the procedures and conditions that are involved with the process of extraction and detection of the analyte.
The process of Bioanalysis and the production of toxicokinetic, pharmacokinetic, and metabolic data plays an elementary role in research and development involved with drug discovery and the following development process. Method development consists of the optimization of the following Bioanalytical parameters to ensure that the method is appropriate for validation:
- Reference standards
- Critical reagents
- Selectivity and specificity
- Calibration curve
- Quality control samples (QCs)
- Stability of the analyte in the matrix
The Bioanalytical method development, however, does not require an all-embracing record-keeping process. However, the sponsor is required to record all alterations to the procedures as well as any issues that might have cropped up and their clarification or rectification, during the development process of the Bioanalytical method, so as to provide an underlying principle for the same.
Bioanalytical method validation also requires that the optimized method is well suited to the analysis of the study samples. The sponsor should:
- Conduct a thorough validation of the bioanalytical method that looks into the study of the new drug entity, its metabolite(s), etc
- Conduct a thorough validation for any revisions implemented to an existing validated method
- Record a detailed and written description of the bioanalytical method used before initiating the process of validation. The description must address the critical parameters used in the method right from the time of collection to analysis.
- Document all experiments used in the entire process for drawing conclusions about the validity of the method.
- Validate the measurement of the analyte in the biological matrix.