What is the purpose of Bioanalysis?

Bioanalysis is the quantitative determination of drugs and their metabolites in biological fluids. This technique is used very early in the drug development process to provide support to drug discovery programs on the metabolic fate and pharmacokinetics of chemicals in living cells and in animals.

How do you validate a bioanalytical method?

Bioanalytical method validation comprises all criteria determining data quality, such as selectivity, accuracy, precision, recovery, sensitivity, and stability. This SOP is applicable for the analysis of pre- clinical as well as clinical samples.

What is quantitative Bioanalysis?

Bioanalytical methods are widely used for quantitative estimation of drugs and their metabolites in physiological matrices. These methods could be applied to studies in areas of human clinical pharmacology and toxicology.

What is bioanalytical data?

Bioanalysis is a term generally used to describe the quantitative measurement of a compound (drug) or their metabolite in biological fluids, primarily blood, plasma, serum, urine or tissue extracts.[25] A bioanalytical method consists of two main components.

What is bioanalytical development?

Bioanalytical method development is the quantitative determination of drugs and metabolites in biological matrices such as blood, serum, plasma, urine, tissue, and skin samples as applied to toxicology, pharmacology, bioequivalence, pharmacokinetics, and bioavailability studies in animals or humans.

What is recovery in bioanalytical method?

Low overall analyte recovery is the net result of losses that can happen for multiple reasons at all steps of sample preparation and analysis. Therefore, identifying the source(s) of analyte loss during sample preparation can help guide the optimization the bioanalysis conditions to minimize these losses.

What is matrix effect in Bioanalysis?

Matrix effects are often caused by the alteration of ionization efficiency of target analytes in the presence of co-eluting compounds in the same matrix. Matrix effects can be observed either as a loss in response (ion suppression) or as an increase in response (ion enhancement).