vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-127Research ArticleДОКЛИНИЧЕСКОЕ И КЛИНИЧЕСКОЕ ИЗУЧЕНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВPRECLINICAL AND CLINICAL STUDY OF MEDICINESОценка фармакокинетики эндогенных соединений на примере препаратов кальцияEvaluation of endogenous compounds pharmacokinetics as illustrated by calciumЕременкоН. Н.EremenkoN. N.noemail@neicon.ruГорячевД. В.GoryachevD. V.noemail@neicon.ruШихЕ. В.ShikhE. V.noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation20171302201872104110Copyright © Еременко Н.Н., Горячев Д.В., Ших Е.В., 20182018Еременко Н.Н., Горячев Д.В., Ших Е.В.Eremenko N.N., Goryachev D.V., Shikh E.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/127

В статье представлен анализ данных научной литературы по вопросам проведения фармакокинетических исследований invivo лекарственных препаратов, аналогов эндогенных соединений. Рассмотрены подходы к оценке фармакокинетических параметров лекарственных препаратов кальция. Установлено, что для оценки фармакокинетических параметров лекарственных препаратов, содержащих в своем составе ионы кальция в виде различных солей, необходимо изучение нескольких фармакокинетических параметров: параметры, характеризующих абсорбцию кальция (Cmax и AUC с учетом фоновых эндогенных концентраций кальция), гомеостатические механизмы, регулирующие концентрацию данного эндогенного соединения (параметры выведения кальция), а также гормональную регуляцию фосфатно-кальциевого гомеостаза (паратиреоидный гормон).

The article reviews scientific literature on the conduct of in vivo pharmacokinetic studies of drugs that are similar to endogenous compounds. It summarises approaches to pharmacokinetic evaluation of calcium drugs. It was demonstrated that the pharmacokinetic evaluation of drugs containing calcium ions in the form of various salts requires assessment of several parameters: parameters indicative of calcium absorption (Cmax and AUC with due regard to baseline concentrations of endogenous calcium), homeostatic mechanisms which regulate the concentration of this endogenous compound (calcium excretion parameters) and hormonal regulation of phosphate and calcium homeostasis (parathyroid hormone).

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The authors declare that there are no conflicts of interest present.