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Robust development and validation of bioanalytical methods and their importance in making accurate drug, metabolite, and biomarker measurements.  

FREMONT, CA: Bioanalysis is not necessarily running standard tests. As these analyses constitute the fundamental block to drug approval, we must generate quantitative and reliable findings as per FDA guidance. Due to such analyses' value, these findings are usually audited by regulatory authorities for accuracy before the drug is approved. When the dynamics of bioanalysis are cumbersome, it is imperative to have veterans' assistance and experience, such as the team at NorthEast BioLab. Following method creation based on the required detection range for your assay, our scientists help navigate bioanalytical method validation, as well as provide insights into the criteria of the FDA and other international regulatory authorities.

Robust development and validation of bioanalytical methods is essential for accurate drug, metabolite, and biomarker measurements in bioanalytical assays. During bioanalytical analysis, many underlying steps are correctly completed. Above all, the essence and any related characteristics of the sample have to be determined and considered.

Bioanalytical method development and validation guidelines are issued by the FDA, ICH, and other regulatory agencies, detailing the necessary criteria for effective bioanalytical development, validation, and review. 

For any custom assay method that is new or developed based on the literature, a complete validation analysis should be carried out. A completely validated procedure demonstrates that the concentrations of analytes such as a drug and its metabolite(s) can be accurately calculated using it. Sensitivity selectivity, reproducibility, intra-, and inter-day precision and accuracy, dilutional integrity, matrix effects, and analyte stability under all storage and sample handling and preparation conditions are the main features that need to be determined for the performance of a system to be deemed appropriate.

The ppt and report validation bioanalytical method should contain all the required validation information that has been performed. For any required method information, the SOPs generated during method creation should be referred to in the validation report. All the source data should be available in the original format upon request. It is necessary to report any deviations from the validation protocol. Reference should be made to the validation report in the ppt and report for the development of the bioanalytical method. Otherwise, the report for the result of the bioanalytical process discusses the technique and samples' specifics and the actual data produced.