Why (not) go east? comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world

Drug Design, Development and Therapy

Volumn 6, Issue , 2012, Pages 53-60

  Caldron, Paul H ^a   Gavrilova, Svetlana I ^b   Kropf, Siegfried ^c  

^a MIDWESTERN UNIVERSITY   (United States)

^b MENTAL HEALTH RESEARCH CENTER   (Russian Federation)

^c OTTO VON GUERICKE UNIVERSITY   (Germany)

Author keywords

Central and Eastern Europe (CEE); Clinical trials; Data quality; Deficiencies; Inspection

Indexed keywords

NEW DRUG;

ARTICLE; CHINA; CLINICAL RESEARCH; CLINICAL STUDY; CONTROLLED STUDY; DRUG RESEARCH; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; INDIA; NORTH AMERICA; QUALITY CONTROL; SOUTH AFRICA; SOUTH AND CENTRAL AMERICA; STANDARDIZATION; UNITED STATES;

EID: 84863740171     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/dddt.s30109     Document Type: Article

References (12)

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