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Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics

Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by national laws in line with the directive, EMA gui...

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Detalhes bibliográficos
Publicado no:Br J Clin Pharmacol
Main Authors: Ollivier, Cécile, Thomson, Andrew, Manolis, Efthymios, Blake, Kevin, Karlsson, Kristin E., Knibbe, Catherijne A.J., Pons, Gérard, Hemmings, Robert
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6422728/
https://ncbi.nlm.nih.gov/pubmed/30707770
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13883
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