Serious Adverse Drug Reaction
- Serious Adverse Drug Reaction
Серьезное побочное явление или серьезная побочная реакция на лекарственный препарат
Любые неблагоприятные клинические проявления, которые независимо от дозы лекарственного средства: приводят к смерти; представляют угрозу для жизни; требуют госпитализации или продления срока госпитализации; приводят к стойкой или выраженной нетрудоспособности/ инвалидности; являются врожденной аномалией/пороком развития. (См. руководство ICH «Clinical Safety Data Management: Definitions and Standards/or Expedited Reporting»).
English-Russian glossary of clinical practice.
2002.
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