Perspectives
One size does not fit all: getting drug doses right for children
1 Institute of Child Health, Royal Liverpool Children’s Hospital, Liverpool, UK
2 School of Reproductive and Developmental Medicine, University of Liverpool, Alder Hey Children’s Hospital, Liverpool, UK
Correspondence to:
Professor R L Smyth, Division of Child Health, School of Reproductive and Developmental Medicine, University of Liverpool, Alder Hey Children’s Hospital, Liverpool L12 2AP, UK; r.l.smyth@liv.ac.uk
| The first 150 words of the full text of this article appear below. |
The European Regulation on Better Medicines for Children1 requires companies that wish to develop a drug for use in Europe to agree a paediatric investigation plan (PIP) if the drug may have an indication for use in children. This very important legislation means that many more drugs will be investigated in children. New methodologies will be required to enable appropriate evaluation of drugs at all ages. Defining the optimal dose of a drug is one of the most difficult parts of the development process. Standard pharmacokinetic/pharmacodynamic (PK/PD) approaches, such as those used in phase I trials of healthy adults, involve administering either single or multiple doses of a drug to a small group of study participants. Blood samples are taken from participants at specified time intervals, based on absorption and distribution half-lives, and subsequently assayed for concentrations of drug and relevant metabolites. These data are pharmacokinetic parameters, and the effect
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Arch. Dis. Child. 2008 93: 207-211.[Abstract] [Full Text] [PDF]
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