The quality and characteristics of clinical drug study notifications reviewed by the regulatory agency in Finland

Controlled Clinical Trials

Volumn 23, Issue 1, 2002, Pages 42-51

  Keinonen, Tuija ^a,b   Nieminen, Sakari ^c   Saareks, Virpi ^d,e   Miettinen, Pirkko ^f   Saano, Veijo ^f   Ylitalo, Pauli ^d,e  

^a UNIVERSITY OF EASTERN FINLAND   (Finland)

^b Oy Medfiles Ltd   (Finland)

^c KUOPIO UNIVERSITY HOSPITAL   (Finland)

^d Department of Pharmacological Sciences ^*  (Finland)

^e TAMPERE UNIVERSITY HOSPITAL   (Finland)

^f NATIONAL AGENCY FOR MEDICINES   (Finland)

Author keywords

Approval process; Clinical trials; Drug evaluation; Feasibility studies; Government agencies; Practice guidelines

Indexed keywords

PLACEBO;

ARTICLE; CHEMICAL ANALYSIS; CLINICAL TRIAL; FEASIBILITY STUDY; FINLAND; GOOD CLINICAL PRACTICE; GOVERNMENT; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; QUALITY CONTROL; RETROSPECTIVE STUDY; UNIVERSITY HOSPITAL; VALIDATION PROCESS;

CLINICAL TRIALS; ETHICS COMMITTEES, RESEARCH; FINLAND; HUMANS;

EID: 0036173411     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(01)00181-7     Document Type: Article

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