Клинические исследования лекарственных средств у беременных: отношение ожидаемой пользы к возможному риску?

С точки зрения фармакотерапии беременность представляет собой специфическую фазу жизни, которая отличается от всех других фаз жизни по медицинским, этическим и правовым основам. В статье рассматриваются научные, этические и некоторые регуляторные принципы включения беременных женщин в клинические исследования лекарственных средств, обосновывается необходимость их проведения с позиции клинической фармакологии. Клиническая ценность исследований по оценке отношения ожидаемой пользы к возможному риску при проведении фармакотерапии у беременных диктует необходимость развития данного научного направления.

pregnancy, drugs, clinical trials, safety, efficacy, metabolism, pharmacogenetics, беременность, лекарственное средство, клиническое исследование, безопасность, эффективность, метаболизм, фармакогенетика

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