Application of Bioanalysis in Drug Discovery and Drug Development Process
Biological analysis refers to the quantitative analysis of target substances in biological matrices using techniques such as chromatography, chromatography-mass spectrometry, and ligand binding. Biological analysis includes the analysis of large and small molecules such as drugs, metabolites, proteins, and peptides in the matrix. In the pharmaceutical industry, bioanalysis has been widely used in drug discovery and drug development processes, such as pharmacokinetics, toxicokinetics, consistency evaluation, bioavailability, pharmacodynamics, etc. It also has broad applications in many non-pharmaceutical research fields, such as forensic analysis, doping control and identification, qualitative and quantitative analysis of biomarkers for disease diagnosis, etc.
The objects of biological analysis are biological matrices or biological samples, which usually include: serum, plasma, skin, blood, urine, saliva, tears, cerebrospinal fluid and other organ tissues, etc. Its particularity is manifested in the following aspects:
- complex composition of biological matrix;
- a type of matrix that is very scarce or difficult to obtain (eg cerebrospinal fluid);
- The same individual at different times or in different states, or there are large differences between different individuals and races;
- Low drug concentrations in biological samples.
Biological samples usually require pretreatment before analysis. Common pretreatment methods for biological samples include: Liquid-Liquid Extraction, solid-phase extraction (hase Extraction), and Protein Precipitation.
Since biological samples are generally derived from whole blood, serum, plasma, urine or other clinical biological samples, they have small sampling amount, low drug concentration, many interfering substances (such as hormones, vitamins, bile and other drugs that may be taken with them) and individual differences. Therefore, it is necessary to establish a sensitive, specific, accurate and reliable quantitative analysis method for biological samples according to the structure of the analyte, the biological medium and the expected concentration range, and to confirm the method.
The most commonly used analysis methods are:
(1) Chromatography: gas chromatography (GC), high performance liquid chromatography (HPLC), chromatography-mass spectrometry (LC-MS, LC-MS-MS, GC-MS, GC-MS-MS), etc., Can be used for the detection of most drugs;
(2) Immunological methods: radioimmunoassay, enzyme immunoassay, fluorescence immunoassay, etc., which are mostly used for the detection of protein and polypeptide substances;
(3) Microbiological methods: can be used for the determination of antibiotic drugs.
It is precisely because of the characteristics of biological matrices and the complexity of the bioanalytical process that bioanalytical methods must ensure reliable and reproducible results over time, and Bioanalytical Method Validation (BMV) helps to obtain Reliable results, which are necessary for correct decisions on drug dosage and patient safety.
AxisPharm is a San Diego based bioanalytical LC/MS/MS service provider with more than 25 years experience in the field. Our bioanalytical chemistry department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LCMS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in various biological matrices and can provide bioanalytical support throughout all the stages of drug development.
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