Since the 90% CI for AUC(last), AUC(0-inf) and C(max) ratios were within in the 80-125% interval proposed by the US FDA, it was concluded that Amlodipine 5 mg tablet (test formulation) was bioequivalent to Norvasc 5 mg tablet, in terms of both rate and extent of absorption.
This study suggests that indoor air-related respiratory symptoms are a matter of concern in places with hot and humid climate. The regression models were adjusted by confounders that could be used in further reanalysis of indoor air quality related symptoms and ventilation systems with expanded variety of climatic conditions.
In Brazil, a herbal medicinal extract named Catuama containing a mixture of Paullinia cupana (guarana; Sapindaceae), Trichilia catigua (catuaba; Meliaceae), Ptychopetalum olacoides (muirapuama; Olacaceae) and Zingiber officinale (ginger; Zingiberaceae) is used as a body stimulant, energetic, tonic and aphrodisiac. The present study investigated the chronic administration of 25 mL Catuama twice a day during 28 days for any toxic effect on healthy human volunteers of both sexes. No severe adverse reactions or haematological and biochemical changes were reported.
An analytical method based on liquid chromatography with positive ion electrospray ionization (ESI) coupled to tandem mass spectrometry detection was developed for the determination of pantoprazole (CAS 102625-70-7) in human plasma using lansoprazole (CAS 103577-45-3) as the internal standard. The analyte and internal standard were extracted from the plasma samples by liquid/liquid extraction using diethyl-ether/dichloromethane (70:30; v/v) and chromatographed on a C8 analytical column. The mobile phase consisted of acetonitrile/ water/methanol (57:25:18; v/v/v) + 10 mmol/l acetic acid + 20 mmol/l ammonium acetate. The method has a chromatographic total run time of 4.5 min and was linear within the range 5.0-5,000 ng/ mL. Detection was performed on a triple quadrupole tandem mass spectrometer by Multiple Reaction Monitoring (MRM). The intra- and inter-run precisions calculated from quality control (QC) samples were 4.2 % and 3.2 %, respectively. The accuracies as determined from QC samples were -5.0 % (intra-run) and 2.0 % (inter-run). The method herein described was employed in a bioequivalence study of two tablet formulations of pantoprazole.
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