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| Titel: |
Clinical trials for paediatric medicines in Europe |
| Auteur: |
Baiardi, P. Girotto, S. Della Pasqua, O. Harper, L. Grosch-Wörner, I. Ceci, A. Giaquinto, C. |
| Verschenen in: |
Pharmaceuticals policy and law |
| Paginering: | Jaargang 11 (2009) nr. 1-2 pagina's 71-78 |
| Jaar: |
2009-03-10 |
| Inhoud: |
For years the lack of studies specifically designed to investigate pharmacological and toxicological aspects in the paediatric population has forced children to use many approved drugs without a proper information on dosage, efficacy and safety and on the basis of data extrapolated from adults studies. In Europe, the Directive EC/2001/20 on Good Clinical Practice, was the first to take into consideration the need of performing clinical trials in children in compliance with the current GCP requirements. Moreover, the Note for Guidance ICH Topic E11 gives recommendations on clinical trials' characteristics. Our study found that under the EMEA centralised procedure, 60 drugs were licensed for use in children in the period 1995–2005. These data show an increasing trend in the percentage of EMEA approved medicines for children compared with previously reported figures. Moreover, few clinical studies were performed in compliance with the paediatric age groups as defined by the ICH/E11 guideline. This is of particular concern especially when the adolescent age group is considered, since adolescents are frequently recruited together with adults. The new Paediatric Regulation, in force from January 2007, is expected to dramatically change this situation. |
| Uitgever: |
IOS Press |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 4 van 13 gevonden artikelen
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