Фармакометрика как инструмент клинической фармакологии для оптимизации режима дозирования лекарственных средств во время беременности
Автор: Решетько О.В., Луцевич К.А.
Журнал: Саратовский научно-медицинский журнал @ssmj
Рубрика: Фармакология
Статья в выпуске: 1 т.10, 2014 года.
Бесплатный доступ
Изменения физиологических и метаболических процессов во время беременности оказывает влияние на фармакокинетику лекарственных средств, иллюстрируя возможность некорректности стандартного режима до- зирования во время беременности. Различные фармакометрические подходы доступны для дизайна и анализа клинических исследований во время беременности. Физиологически обоснованная фармакокинетическая (physiology-based pharmacokinetic, РВРК) модель может быть использована для оценки различных режимов дозирования ЛС у беременных женщин и полезна в предсказании лекарственного воздействия и ответа на него на индивидуальном уровне.
Беременность, фармакокинетика, фармакометрика
Короткий адрес: https://sciup.org/14917916
IDR: 14917916
Список литературы Фармакометрика как инструмент клинической фармакологии для оптимизации режима дозирования лекарственных средств во время беременности
- Hasselt JGC van, Andrew MA, Hebert MF, et al. The status of pharmacometrics in pregnancy: highlights from the 3rd American conference on pharmacometrics. Br J Clin Pharmacol 2012; 74:932-939
- Ke AB, Rostami-Hodjegan A, Zhao P, Unadkat JD. Pharmacometrics in pregnancy: an unmet need. Annu Rev Pharmacol Toxicol 2014; 54: 53-69
- Woosley RL, Cossman J. Drug development and the FDA's Critical Path Initiative. Clin Pharmacol Ther 2007; 81: 129-133
- Waldman SA, Christensen NB, Moore JE, TerzicA. Clinical pharmacology: the science of therapeutics. Clin Pharmacol Ther 2007; 81: 3-6
- Waldman SA, Hohl RJ, Kearns GL, Swan SJ, Terzic A. Clinical pharmacology as a foundation for translational science. Clin Pharmacol Ther 2011; 90: 10-13
- Waldman SA, Graaf PH van der, Terzic A. Systems approaches evolve clinical pharmacology. CPT: Pharmacometrics & Systems Pharmacology 2013; 2: e68
- Graaf PH van der. CPT: Pharmacometrics and Systems Pharmacology. CPT: Pharmacometrics & Systems Pharmacology 2012;1:e8
- Vicini P, Graaf PH van der. Systems pharmacology for drug discovery and development: paradigm shift or flash in the pan? Clin Pharmacol Ther 2013; 93: 379-381
- Sorger PK, Allerheiligen SRB, Abernethy DR, et al. Quantitative and Systems Pharmacology in the Post-genomic Era: New Approaches to Discovering Drugs and Understanding Therapeutic Mechanisms. An NIH White Paper, QSP Workshop Group (2011). http://isp.hms.harvard.edu/wordpress/wpcontent/uploads/2011/10/N IH-Systems-Pharma-Whitepaper-Sorger-et-al-2011.pdf
- Graaf PH van der, Benson N. Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development. Pharm Res 2011; 28: 1460-1464. 11. Derendorf H, Meibohm B. Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives. Pharm Res 1999; 16: 176-85
- Pfister M, D'Argenio DZ. The emerging scientific discipline of pharmacometrics. J Clin Pharmacol 2010; 50 (9 Suppl): 6S
- Smith BP, Vincent J. Biostatistics and pharmacometrics: quantitative sciences to propel drug development forward. Clin Pharmacol Ther 2010; 88: 141 -144
- Corley RA, Mast TJ, Carney EW, et al. Evaluation of physiologically based models of pregnancy and lactation for their application in children's health risk assessments. Crit Rev Toxicol 2003; 33: 137-211
- Anger GJ, Piquette-Miller M. Pharmacokinetic studies in pregnant women. Clin Pharmacol Ther 2008; 83: 184-187
- Andrew MA, Easterling TR, Carr DB, et al. Amoxicillin pharmacokinetics in pregnant women: Modeling and simulations of dosage strategies. Clin Pharmacol Ther 2007; 81: 547-556
- Freeman MP, Nolan PE Jr, Davis MF, et al. Pharmacokinetics ofsertraline across pregnancy and postpartum. J Clin Psychopharmacol 2008; 28: 646-653
- Haas DM, Gallauresi B, Shields K, etal. Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy. Clin Transl Sci 2011; 4:204-209
- HebertMF, Carr DB, Anderson GD, etal. Pharmacokinetics and pharmacodynamics of atenolol during pregnancy and postpartum. J Clin Pharmacol 2005; 45: 25-33
- Hebert MF, Ma X, Naraharisetti SB, et al. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther 2009; 85: 607-614
- Zheng S, Easterling TR, Umans JG, et al. Pharmacokinetics of tacrolimus during pregnancy. Ther Drug Monit 2012; 34: 660-670
- Mirochnick M, Best BM, Clarke DF. Antiretroviral pharmacology: special issues regarding pregnant women and neonates. Clin Perinatol 2010; 37: 907-927
- Sheiner L, Wakefield J. Population modelling in drug development. Stat Methods Med Res 1999; 8: 183-193
- Fischer JH, Sarto GE, Habibi M, et al. Influence of body weight, ethnicity, oral contraceptives, and pregnancy on the pharmacokinetics of azithromycin in women of childbearing age. Antimicrob Agents Chemother 2012; 56: 715-724
- Taming J, McGready R, Lindegardh N, et al. Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria. Antimicrob Agents Chemother 2009; 53: 3837-3846
- Benaboud S, Hirt D, Launay O, et al. Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. Antimicrob Agents Chemother 2012; 56: 857-862
- Rowland M, Peck C, Tucker G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 2011; 51: 45-73
- Andrew MA, Hebert MF, Vicini P. Physiologically based pharmacokinetic model of midazolam disposition during pregnancy. Annual International Conf Proc IEEE Eng Med Biol Soc 2008; 2008: 5454-5457
- Jamei M, Dickinson GL, Rostami-HodjeganA.Aframework for assessing inter-individual variability in pharmacokinetics using virtual human populations and integrating general knowledge of physical chemistry, biology, anatomy, physiology and genetics: A tale of 'bottom-up' vs 'top-down' recognition of covariates. Drug Metab Pharmacokinet 2009; 24: 53-75
- Zhao P, Zhang L, Grillo JA, et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther 2011; 89: 259-267
- Ke AB, Nallani SC, Zhao P, et al. A PBPK model to predict disposition of CYP3A-metabolized drugs in pregnant women: Verification and discerning the site of CYP3A induction. CPT Pharmacometrics Systems Pharmacology 2012; 1: e3
- Gaohua L, Abduljalil K, Jamei M, et al. Physiologically-based pharmacokinetic (PBPK) models for assessing the kinetics of xenobiotics during pregnancy: achievements and shortcomings. Curr Drug Metab 2012; 13: 695-720.