Author:
Consolaro Alessandro,Ruperto Nicola
Reference38 articles.
1. Taubes G. Medical research: use of placebo controls in clinical trials disputed. Science. 1995;267:25–6.
2. Ruperto N, Martini A, for the Paediatric Rheumatology International Trials Organization (PRINTO). Use of unlabelled and off licence drugs in children. A European paediatric rule is needed to protect children. BMJ. 2000;320:1210–1.
3. Ruperto N, Giannini EH, Pistorio A, Brunner HI, Martini A, Lovell DJ. Is it time to move to active comparator trials in juvenile idiopathic arthritis? A review of current study designs. Arthritis Rheum. 2010;62:3131–9.
4. Food and Drug Administration (FDA). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologic products in pediatrics patients (21 CFR Parts 201, 312, 314, and 601). Fed Regist. 1998;63(231):66631–72.
5. Regulation (EC) no 1901/2006 of the European parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Off J Eur Union. 2006; L 378:1–19.