Innovative regulatory-conforming bioanalytical approaches enabling systematic investigations of pharmacokinetics and pharmacodynamics by paediatric clinical studies in all age groups
Conclusion
The child-appropriate bioanalytical platform can be applied in upcoming paediatric Phase II and Phase III studies of the LENA (Labeling of Enalapril from Neonates up to Adolescents) project. Meaningful concentration-time profiles with 6–7 sampling points can be obtained even in neonates without infringing ethical recommendations on trial-related blood lost.
The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).
Source: Archives of Disease in Childhood - Category: Pediatrics Authors: Burckhardt, B. B., Tins, J., Läer, S. Tags: POSTER PRESENTATIONS Source Type: research
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