Biomarker analysis in blood or other bodily fluids at either the DNA or protein level has been used by physicians for decades to study human diseases. Physicians readily rely on biomarker services to diagnose and manage clinical conditions such as cardiovascular diseases, cancer, immune responses, and genetic disorders. However, the application of biomarker assay in research has recently exploded out of a desire to gain crucial information about biological reactions upon exposure to novel therapeutic compounds.
Biomarker testing services provide a powerful approach to measuring biological process indicators in normal and pathological conditions or in response to pharmacological intervention. Biomarker analysis in blood or other bodily fluids at either the DNA or protein level has been used by physicians for decades to study human diseases. Many researchers use biomarker analysis to elucidate the effects of treatments and exposures on cells, tissues, organs and whole organisms. Biomarkers are indicators of normal or abnormal biological processes in humans, animals and plants.
The biomarker analysis market is experiencing a significant change as new technologies become commercially viable. These changes provide significant opportunities for the development of new assays and the expansion of existing ones, particularly those used to predict the metabolic breakdown of drugs in clinical trials and drug discovery.
Analytical method development is a procedure for reliable detection of analytes of interest. High-grade method development ensures that the method is suitable for full validation and high-quality analysis of drugs, metabolites, and biomarkers in biological matrices. A new drug may be compounds never used before or modification of existing drugs. Inability to relate analytical procedures, as well as reference and internal standards for new drugs, hinders their thorough R&D. Hence, it becomes necessary to develop new analytical methods for studying the effect of drug compounds. These methods are designed to understand the identity, characteristics, purity, and potency of drug compounds.
As the number of drugs released in the market is increasing by the day, so is the need for method development and validation. These new drugs may be compounds never used before or modification of existing drugs. Inability to relate analytical procedures, as well as reference and internal standards for new drugs, hinders their thorough R&D. Hence, it becomes necessary to develop new analytical methods for studying the effect of drug compounds. These methods are designed to understand the identity, characteristics, purity, and potency of drug compounds. The need for developing analytical methods for drugs has been on the increase with the number of new drugs released in the market. The ability to relate analytical procedures, as well as reference and internal standards for new drugs, hinders their thorough research. Hence, it becomes necessary to develop new methods for studying the effect of drug compounds.
Method development is a procedure for reliable detection of analytes of interest. Method development ensures that the method is suitable for high-quality analysis of drugs, metabolites, and biomarkers in biological matrices. Today there are more than 5,000 compounds being developed as new drugs. However, without establishing analytical methods for the identification and purity measurement of these drug compounds, it becomes difficult to determine their effects on humans, animals and plants.
