Les essais thérapeutiques en néonatologie
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In view of the specific pharmacodynamics and pharmacokinetics in neonates, it is necessary to evaluate drugs for use in this age range. The difficulties of performing drug trials in neonates, the application of the law which protects individuals and the small market represented by neonatal prescription, all account for the delay in the evaluation of drugs for this group of patients. Classical methodological rules can be applied without exception to neonatology, but with particular attention to physiological development. The precise measurement of the effects of drugs, often difficult in neonatology, requires the adaptation of the means of measuring these effects.
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Autret, E. ; Jonville, A.P., Les essais thérapeutiques en néonatologie, Med Sci (Paris), 1993, Vol. 9, N° 3; p.266-270