How to improve complex drug development? A critical review of FDA advisory meetings

Drug Information Journal

Volumn 41, Issue 5, 2007, Pages 673-683

  Boudes, Pol F ^a  

^a BAYER CORPORATION   (United States)

Author keywords

Drug approval; Effect size; Safety; Trials; US Food and Drug Administration

Indexed keywords

CLOFARABINE; DOCETAXEL; EFAPROXIRAL; MARQIBO; OBLIMERSEN; PEGAPTANIB; PEMETREXED; TAZAROTENE; TEGASEROD; TESTOSTERONE; UNCLASSIFIED DRUG; VINCRISTINE SULFATE; WARFARIN; XIMELAGATRAN;

BREAST CANCER; CARDIOVASCULAR DISEASE; COLITIS; CORONARY ARTERY DISEASE; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; ENDOPHTHALMITIS; FOOD AND DRUG ADMINISTRATION; FRACTURE; HUMAN; LIVER TOXICITY; PRIORITY JOURNAL; RETINA DETACHMENT; REVIEW; RISK BENEFIT ANALYSIS; TERATOGENICITY;

EID: 35148895216     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150704100514     Document Type: Review

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