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Recently, the USFDA issued the new 2018 guidance document for the industry on bioanalytical validation. Due to this occasion, it would be worthy to look back in time as well
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Immunocapture-LC/MS has recently been used for quantitating therapeutic proteins/peptides and biomarkers in various matrices. The advantages of LC/MS quantitation include high specificity and selectivity, wide dynamic range, and less susceptibility
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Clinical studies on tuberculosis have shown a correlation between low drug exposure and treatment failure and acquired drug resistance. Objective was to develop a LC-MS/MS method for the quantification of
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Microbial products continue to represent one of the most interesting sources for the discovery and development of novel drugs. As a result of the massive screening of microbes since 1950,
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Antibodies play a key role in the immune response. Since antibodies bind antigens with high specificity and tight affinity, Monoclonal antibodies are therapeutic drugs and used for vaccine development. Antibody
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The discoveries and insights made using pharmacometabolomics and high-resolution mass spectrometry, and the tradition of TDM to precisely quantify the target drug and/or metabolites can form a fundament for developing
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Analysis of biopharmaceuticals is very complex. It requires a suite of analytical methods and state-of-the-art instruments with maximal resolving power. 2D-LC provides high chromatographic selectivity and resolving power by combining
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Immunoassays have been the technology of choice for the analysis of biomolecules for many decades across a wide range of applications in research, diagnostics and infectious disease monitoring. There are
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Bone morphogenetic protein-2 (BMP-2) is an osteoinductive and osteointegrating signaling molecule. It is secreted in the human body as a glycoprotein and the molecular weight of its dimer isoforms are
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Steroid profiling can be used to discriminate between healthy individuals and individuals with an adrenal disorder, such as Cushing’s syndrome, Addison’s disease or congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH)
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