Importance of Regulated Bioanalysis in Clinical Research
Bioanalytical reports are essential documents that present the results of measuring drug concentrations, metabolites, biologics, and biomarkers in biological matrices (e.g., blood, serum, plasma, saliva, urine, CSF, or tissue), an essential aspect of therapeutic product development. They provide the basis for pharmacokinetic and toxicokinetic evaluations and support regulatory submissions. These essential documents demonstrate the quality and validity of the data obtained from measuring drug concentrations or biomarkers in biological samples.