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Bioanalytical methods should be reproducible and consistent when applying to clinical sample analysis. Incurred sample reanalyses (confirmatory reanalyses) are performed to support clinical data, and regulatory agencies evaluate the same before approval of bioequivalent products/drugs. A...
In recent years, the growth of clinical research has gone up globally, and countries from Asia are gaining in importance. Being the preferred hub for clinical research because of its young, highly educated work-force, prevalence of all major diseases, and, most importantly, use of English as the...
Clinical trials using human subjects are an integral part of the approval of new drugs and biologics. According to Center Watch, 86% of US clinical studies fail to recruit the required number of subjects on time. It is therefore logical that pharmaceutical companies would turn to global...
An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and...
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