Pharmacokinetic properties and safety assessment of the generic vaginal gel progesterone preparation: results of an open-label, randomized, crossover bioequivalence study
- Авторлар: Tapilskaya N.I.1,2, Gzgzyan A.M.1,3, Kogan I.Y.1,3, Pisarev V.V.4, Merkulov M.E.4, Korneeva I.E.5
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Мекемелер:
- D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction
- Saint Petersburg State Pediatric Medical University, Ministry of Health of Russia
- Saint Petersburg State University
- Medical Center Probiotech LLC
- Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
- Шығарылым: № 8 (2022)
- Беттер: 144-152
- Бөлім: Articles
- URL: https://journals.eco-vector.com/0300-9092/article/view/249582
- DOI: https://doi.org/10.18565/aig.2022.8.144-152
- ID: 249582
Дәйексөз келтіру
Аннотация
Негізгі сөздер
Толық мәтін
Авторлар туралы
Natalya Tapilskaya
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction; Saint Petersburg State Pediatric Medical University, Ministry of Health of Russia
Email: tapnatalia@yandex.ru
MD, PhD, DSci (Medicine), Professor, Leading researcher at the Department of Reproduction
Alexander Gzgzyan
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction; Saint Petersburg State University
Email: iagmail@ott.ru
MD, PhD, DSci (Medicine), Head of the Department of Reproduction
Igor Kogan
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction; Saint Petersburg State University
Email: ikogan@mail.ru
MD, PhD, DSci (Medicine), Professor, Corresponding Member of RAS, Director; Professor at the Department of Obstetrics, Gynecology and Reproduction, Medical Faculty
Vladimir Pisarev
Medical Center Probiotech LLC
Email: vladimir.pisarev@probiotech.ru
MBA, Head
Mikhail Merkulov
Medical Center Probiotech LLC
Email: mikhail.merkulov@probiotech.ru
specialist
Irina Korneeva
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: irina.korneeva@inbox.ru
MD, PhD, DSci (Medicine), Professor, Senior Researcher at the Scientific and Clinical Department of Assisted Reproductive Technology named after F. Paulsen
Әдебиет тізімі
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- von Eye Corleta H., Capp E., Ferreira M.B. Pharmacokinetics of natural progesterone vaginal suppository. Gynecol. Obstet. Invest. 2004; 58(2): 105-8. https://dx.doi.org/10.1159/000078842.
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- Тихомиров А.Л. Крайнон® в коррекции функциональных нарушений менструальной функции. РМЖ. Мать и дитя. 2014; 19: 1388.
- Bulletti C., de Ziegler D., Flamigni C., Giacomucci E., Polli V., Bolelli G., Franceschetti F. Targetted drug delivery in gynaecology: the first uterine pass effect. Hum. Reprod. 1997; 12(5): 1073-9. https://dx.doi.org/10.1093/humrep/12.5.1073.
- Совет Евразийской экономической комиссии. Решение от 03 ноября 2016 г. N. 85 «Об утверждении Правил проведения исследований биоэквивалентности лекарственных препаратов в рамках Евразийского экономического союза».
- Levine H., Watson N. Comparison of the pharmacokinetics of crinone 8% administered vaginally versus Prometrium administered orally in postmenopausal women(3). Fertil. Steril. 2000; 73(3): 516-21. https://dx.doi.org/10.1016/S0015-0282(99)00553-1.