Puran Singhal

TL;DR: A simple, sensitive and high throughput liquid chromatography/positive-ion electrospray ionization mass spectrometry (LC-ESI-MS/MS) method has been developed and successfully applied to a bioequivalence study in 41 healthy human subjects after oral administration of 1000 mg valacyclovir tablet formulation under fasting condition.

TL;DR: The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.

TL;DR: A high throughput and rugged ultra performance liquid chromatography tandem mass spectrometry (UPLC-ESI-MS/MS) method is developed and validated for the selective determination of protease inhibitors -- lopinavir (LPV) and ritonavir (RTV) in human plasma.

TL;DR: The method is fully validated for its sensitivity, selectivity, accuracy and precision, ion suppression, matrix effect, recovery, stability, and dilution integrity and is successfully applied to a bioequivalence study of [300(TFV) + 200(FTC) + 300(3TC)] mg tablet formulation in 43 healthy human subjects under fasting conditions.

TL;DR: The UPLC-MS/MS method was applied to support a bioequivalence study of 85 mg sumatriptan+500 mg naproxen sodium fixed dose formulation in 28 healthy Indian subjects and reproducibility was demonstrated by reanalysis of 123 incurred samples.