Clinical Trials in Children and Healthy Volunteers. Quality and Characteristics of Notifications Reviewed by the Regulatory Agency in Finland

Paediatric and Perinatal Drug Therapy

Volumn 5, Issue 4, 2003, Pages 175-182

  Keinonen, Tuija ^a,b   Miettinen, Pirkko ^c   Saano, Veijo ^c   Ylitalo, Pauli ^d,e  

^a UNIVERSITY OF EASTERN FINLAND   (Finland)

^b Oy Medfiles Ltd   (Finland)

^c NATIONAL AGENCY FOR MEDICINES   (Finland)

^d TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^e TAMPERE UNIVERSITY HOSPITAL   (Finland)

Author keywords

Approval process; Children; Clinical trial; Good Clinical Practice; Healthy volunteer

Indexed keywords

NEW DRUG; PLACEBO;

CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG APPROVAL; DRUG SAFETY; DRUG SCREENING; FINLAND; GOOD CLINICAL PRACTICE; HUMAN; INFORMED CONSENT; METHODOLOGY; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROFESSIONAL STANDARD; REVIEW;

EID: 1442310685     PISSN: 14630095     EISSN: None     Source Type: Journal    
DOI: 10.1185/146300903774115766     Document Type: Review

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