Author/Authors :
Turner، نويسنده , , M.A. and Duncan، نويسنده , , J.C. and Shah، نويسنده , , U. and Metsvaht، نويسنده , , T. and Varendi، نويسنده , , H. and Nellis، نويسنده , , G. and Lutsar، نويسنده , , I. and Yakkundi، نويسنده , , S. and McElnay، نويسنده , , J.C. and Pandya، نويسنده , , H. and Mulla، نويسنده , , H. and Vaconsin، نويسنده , , P. and Storme، نويسنده , , T. and Rieutord، نويسنده , , A. J. Nunn، نويسنده , , A.J.، نويسنده ,
Abstract :
Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.
Keywords :
Risk analysis , Pharmaceutical development , Neonates , Adverse effects , excipients , Medicines , Risk management , paediatrics
