A carregar...

Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio

BACKGROUND: Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA’s Benefit–Risk Framework (BRF...

ver descrição completa

Na minha lista:
Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: Sun, Stephen, Heske, Suzanne, Mercadel, Melanie, Wimmer, Jean
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7785542/
https://ncbi.nlm.nih.gov/pubmed/32643080
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-020-00197-1
Tags: Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!