What is Bioanalysis

Biological analysis refers to the quantitative analysis of target substances in biological matrix by chromatography, chromatography-mass spectrometry, ligand binding and other techniques. Bioanalysis includes the analysis of drugs, metabolites, proteins, peptides and other large and small molecules in the matrix. In the pharmaceutical industry, bioanalysis has been widely used in the process of drug discovery and drug development, such as Pharmacokinetics, toxicokinetics, consistency evaluation, bioavailability, pharmacodynamics, and so on. It also has a wide range of applications in many non-pharmaceutical research areas, such as forensic analysis, stimulant control and identification, and qualitative and quantitative analysis of biomarkers for disease diagnosis.

The objects of biological analysis are biological matrix or biological samples, usually including: serum, plasma, skin, blood, urine, saliva, tears, cerebrospinal fluid and other organ tissues, etc. Its particularity is shown in the following aspects:

• Complex biological matrix composition;

• A certain type of matrix is scarce or difficult to obtain (e.g., cerebrospinal fluid);

• The same individual in different time or different states, or between different individuals, ethnic differences;

• Low drug concentrations in biological samples.

Bioanalysis is a multi-step process involving sample collection and storage, processing, sampling analysis, data analysis, and reporting

Biological samples usually require pretreatment before analysis. The commonly used pretreatment methods for biological samples include liquid-liquid Extraction, solid phase Extraction, and Protein Precipitation. Common analytical methods are: Chromatographic Assays (CC) and Ligand Binding Assays (LBA). Due to the characteristics of the biological matrix and the complexity of the biological analysis process, it is required that the biological analysis Method must ensure reliable and repeatable results over a period of time. Bioanalytical Method Validation (BMV) is helpful to obtain reliable results. This is essential for proper dosing and patient safety decisions.