The dynamics of the parathyroid hormone level for the comparative evaluation of calcium absorption from the gastrointestinal tract
Abstract
This article discusses the features of pharmacokinetic parameters evaluation in studies of bioequivalence (BE) on the example of the following drugs: the reference, which in its structure contains 1,000 mg of calcium and 800 IU cholecalciferol (2 tablets) and the test formulation containing 1200 mg of calcium and 1,000 IU cholecalciferol (1 tablet). The results of measurements of parathyroid hormone levels in volunteers at the reception of preparations of calcium; evaluated the excretion ofcalcium in the urine with the terms of creatinine excretion. For conducting expert evaluation of calcium absorption from various medicines offered along with standard way of calculating the area under the curve "concentration — time" total calcium in serum, to assess the excretion of calcium in the urine with the terms of the excretion creatinine and the change in the level of parathyroid hormone.