FDA and EMA end points: Which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?

Neurogastroenterology and Motility

Volumn 25, Issue 6, 2013, Pages 453-457

  Corsetti, M ^a   Tack, J ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Adequate relief; European Medicines Agency; Food and Drug Administration; Irritable bowel syndrome; Patient reported outcome

Indexed keywords

LINACLOTIDE;

CLINICAL TRIAL (TOPIC); CONSTIPATION; EDITORIAL; ENTERITIS; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HUMAN; OUTCOME ASSESSMENT; PATIENT REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL;

ABDOMINAL PAIN; CONSTIPATION; ENDPOINT DETERMINATION; EUROPE; GASTROINTESTINAL AGENTS; HUMANS; IRRITABLE BOWEL SYNDROME; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84877968957     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/nmo.12151     Document Type: Editorial

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