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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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Dettagli Bibliografici
Pubblicato in:Br J Clin Pharmacol
Autori principali: Ollivier, Cécile, Thomson, Andrew, Manolis, Efthymios, Blake, Kevin, Karlsson, Kristin E., Knibbe, Catherijne A.J., Pons, Gérard, Hemmings, Robert
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2019
Soggetti:
Accesso online: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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