Idiopathic pulmonary fibrosis: Clinically meaningful primary endpoints in phase 3 clinical trials

American Journal of Respiratory and Critical Care Medicine

Volumn 187, Issue 11, 2013, Pages 1269-

  Rose, Daniel M ^a   Montgomery, A Bruce ^a  

^a Pulmonary Fibrosis Foundation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE COURSE; DYSPNEA; EXERCISE; FIBROSING ALVEOLITIS; FOOD AND DRUG ADMINISTRATION; HOSPITALIZATION; LETTER; LUNG FUNCTION; MORBIDITY; MORTALITY; NONHUMAN; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUALITY OF LIFE; RARE DISEASE; SURVIVAL;

EID: 84878959520     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201204-0690LE     Document Type: Letter

References (4)

1. Raghu G, Collard HR, Anstrom KJ, Flaherty KR, Fleming TR, King TE Jr, Martinez FJ, Brown KK. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in Phase 3 clinical trials. Am J Respir Crit Care Med 2012;185:1044-1048.
2. Sasinowski F. Quantum of effectiveness evidence in FDA's approval of orphan drugs. Danbury, CT: NORD; 2011.
3. Food and Drug Administration Modernization Act of 1997, Pub L No. 105-115, Stat 2296.
4. TREAT Act, S. 2113, 112th Cong., 2nd Sess. (2012).