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US, EU, and Japanese Regulatory Guidelines for Development of Drugs for Treatment of Alzheimer’s Disease: Implications for Global Drug Development

Drug development guidelines from regulatory authorities provide important information to sponsors on requirements for clinical evidence needed to support approval of new drugs. In the field of Alzheimer’s disease (AD), recently published guidelines are available from EU, US, and Japanese regulatory...

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Detalhes bibliográficos
Publicado no:Clin Transl Sci
Main Authors: Morant, Anne Vinther, Vestergaard, Henrik Tang, Lassen, Anders Blædel, Navikas, Vaidrius
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7359941/
https://ncbi.nlm.nih.gov/pubmed/32043310
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12755
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