Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

British Journal of Clinical Pharmacology

Volumn 63, Issue 2, 2007, Pages 159-162

  Van Luijn, Johan C F ^a,b   Gribnau, Frank W J ^c   Leufkens, Hubert G M ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Health Care Insurance Board ^*  (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Added therapeutic value; Comparative information; EMEA; EPAR; New active substance; Randomized active control trial

Indexed keywords

AGALSIDASE ALFA; ALEMTUZUMAB; ANAGRELIDE; APREPITANT; ARIPIPRAZOLE; ARSENIC TRIOXIDE; ATOSIBAN; BECAPLERMIN; BEVACIZUMAB; BEXAROTENE; BORTEZOMIB; BOSENTAN; CARGLUMIC ACID; CASPOFUNGIN; CETRORELIX; CETUXIMAB; CINACALCET; DARIFENACIN; EFALIZUMAB; ENFUVIRTIDE; FONDAPARINUX; IBRITUMOMAB TIUXETAN; IVABRADINE; LEFLUNOMIDE; RAPAMYCIN; RASBURICASE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; ROSIGLITAZONE; TRASTUZUMAB; UNINDEXED DRUG;

ARTICLE; AUTHORITY; COMPARATIVE STUDY; DATA BASE; DECISION MAKING; DRUG BIOAVAILABILITY; DRUG MARKETING; DRUG MECHANISM; EMBASE; EUROPEAN UNION; EVIDENCE BASED MEDICINE; EVIDENCE BASED PRACTICE; FINANCIAL MANAGEMENT; MEDICAL INFORMATION; MEDICINE; MEDLINE; PRIORITY JOURNAL; PUBLICATION; PUBLISHING;

CLINICAL TRIALS; DRUG APPROVAL; EUROPEAN UNION; EVALUATION STUDIES; HUMANS; LEGISLATION, DRUG;

EID: 33846083812     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02812.x     Document Type: Article

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