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Development and delivery of clinical pharmacology in regulatory agencies

Medicines regulation is based on a foundation of science, policy and judgement. It operates within several frameworks (scientific, legal and public health), which are interdependent. While safety, quality and efficacy remain the criteria by which medicines are assessed, the benefit-to-harm balance f...

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Autore principale: Breckenridge, Alasdair
Natura: Artigo
Lingua:Inglês
Pubblicazione: Blackwell Science Inc 2012
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3391509/
https://ncbi.nlm.nih.gov/pubmed/22360651
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2012.04226.x
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