The term "bioanalysis" refers to the quantitative measurement of analytes (i.e., drugs and their metabolites) and biomarkers in biological matrices such as serum, urine, and different body tissues. In other words, bioanalysis refers to the analytical procedures performed in a laboratory environment on biological samples.
Bioanalysis of the drug begins at the preclinical stage, when the drug is being tested for its efficacy, toxicity, and pharmacokinetics (how the body affects the drug).
The development of bioanalytical methods raises some unique challenges. Two of these challenges are the low limit of detection (the lowest concentration for which the analyte can be distinguished) and the low limit of quantitation (the lowest concentration for which the analyte concentration can be quantified). This challenge is even greater in small animals, where the initial dose is significantly lower.
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Development and validation of bioanalytical methods for quantitation of active drugs, natural compounds, and metabolites.
Testing of tissues and body fluids such as plasma, serum, urine, vitreous fluid, CSF, and cerebral fluid.
Preparation of test articles for pre-clinical efficacy/toxicity studies.