[CITATION][C] Forced vital capacity in idiopathic pulmonary fibrosis—FDA review of pirfenidone and nintedanib
BA Karimi-Shah, BA Chowdhury - New England Journal of …, 2015 - Mass Medical Soc
BA Karimi-Shah, BA Chowdhury
New England Journal of Medicine, 2015•Mass Medical SocIn 2014, the FDA approved two drugs for idiopathic pulmonary fibrosis that posed a
regulatory challenge: the primary efficacy variable studied was the change in forced vital
capacity, which hadn't been established as a surrogate for clinically meaningful benefit.
regulatory challenge: the primary efficacy variable studied was the change in forced vital
capacity, which hadn't been established as a surrogate for clinically meaningful benefit.
In 2014, the FDA approved two drugs for idiopathic pulmonary fibrosis that posed a regulatory challenge: the primary efficacy variable studied was the change in forced vital capacity, which hadn't been established as a surrogate for clinically meaningful benefit.
The New England Journal Of Medicine