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机译:c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper
Neonatal Intensive Care, Women and Child Health Clinic,Pauls Stradins Clinical University Hospital;
Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Medical Faculty;
Regional Center of Pharmacovigilance, Department of Pharmacology,Cochin Hospital, APHP, CentreClinical Trials Consulting and Training LimitedDepartment of Pediatric Pharmacology and Pharmacogenetics, APHP, Robert Debré Hospital;
Center ofDepartment of Paediatrics and Child Health, Max Rady College of Medicine,University of ManitobaPaediatric Clinical Research Center, Queen Silvia Children's Hospital,Sahlgrenska UniversityDepartment of Paediatrics and Adolescent Medicine,University Hospital Erlangen, Friedrich‐AlexanderCentre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li KaDepartment of Pharmacology,Saint‐Louis Hospital;
adverse drug reaction; benefit–risk assessment; clinical trial protocol; paediatric; paediatric investigation plan; pharmacovigilance; risk management; safety specification; signal detection;