Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling.
Nowadays, 50-90% of drugs used in children have never been actually studied in this population. Consequently, either our children are often exposed to the risk of adverse drug events or to lack of efficacy, or they are unable to benefit from a number of therapeutic advances offered to adults, as no clinical study has been properly performed in children. Actually the main methods used to calculate the dose for a child are based on allometric methods taking into account different categories of age, the body weight and/or the body surface area. Unfortunately, these calculation methods consider the children as small adults, which is not the case. Physiologically based pharmacokinetics is one way to integrate the physiological changes occurring in the childhood and to anticipate their impact on the pharmacokinetic processes: absorption, distribution, metabolism and excretion/elimination. From different examples, the application of this modelling approach is discussed as a possible and valuable method to minimize the ethical and technical difficulties of conducting research in children.
Bouzom
F
F
Technologie Servier, 27 rue Eugene Vignat, BP 11749, 45007 Orléans Cedex 1, France. francois.bouzom@fr.netgrs.com
Walther
B
B
D000328:Adult; D000367:Age Factors; D001830:Body Surface Area; D001835:Body Weight; D002648:Child; D002657:Child Development; D002986:Clinical Trials as Topic; D054796:Drug Dosage Calculations; D006801:Humans; D007668:Kidney / Q000378:metabolism; D008099:Liver / Q000378:metabolism; D008954:Models, Biological; D010372:Pediatrics / Q000379:methods*; D010599:Pharmacokinetics; D011485:Protein Binding; D015203:Reproducibility of Results