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Roadmap to risk evaluation and mitigation strategies (REMS) success

Medical safety-related risk management is a rapidly evolving and increasingly important aspect of drug approval and market longevity. To effectively meet the challenges of this new era, we describe a risk management roadmap that proactively yet practically anticipates risk-management requirements, p...

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Detalhes bibliográficos
Main Authors: Balian, John D., Wherry, Janice C., Malhotra, Rachpal, Perentesis, Valerie
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2010
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4110798/
https://ncbi.nlm.nih.gov/pubmed/25083193
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2042098610381419
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