Tamara van Donge

Physiological changes during pregnancy and neonatal life 33 2 specific parameters need to be incorporated into the pregnancy PBPK model and the characterization of the fetal system in terms of enzyme and transporter tissue abundance remains challenging. 6 In addition, obtaining data on fetal drug exposure for the evaluation of the fetal PBPK model continues to be cumbersome. One of the greatest opportunities of using these novel technologies to optimize and personalize pharmacotherapy is at the same time one of the greatest challenges, that is to say the integration of these research-based models in easily accessible software tools which can become part of daily clinical practice. Neoweight is an example of such a user-friendly online prediction tool which can forecasts the individual weight changes during the first week of life, based on three weight measurements and standard characteristics of the newborn, and can be found at http:// neoweight.mashframe.com . 45 We hope that in the near future more validated, user-friendly tools will be developed and integrated in clinical practice. It is rather worrisome that these innovative and novel approaches are being developed in order to ensure safe and effective treatment for the patient, but will never fulfill this goal because of problems with translation, implementation and lack of easy accessibility. Initiatives to build national and international collaborative networks to facilitate clinical trials, and collection and sharing of data are necessary. The Swiss Research Network of Clinical Pediatric Centers (SwissPedNet) and the Swiss Research Center for Pediatric Pharmacology and Pharmacometrics (SwissPedPha) are examples of such national initiatives. In 2012, this research network of pediatric hospitals has been created and has the common goal to facilitate, coordinate and conduct clinical trials in all pediatric disciplines. Another initiative is The Dutch Center for Pharmacotherapy for Children (NKFK) which aims to improve the quality and safety of pharmacotherapy in children and focuses on improving the provision of information about the use of drugs in children. Conclusion The characterization of physiological changes in pregnant women, the description of placental transfer kinetics of drugs, the identification of physiological changes related to the transition from intrauterine to extrauterine life, and the characterization of maturation processes in preterm and term neonates are essential in order to ensure safe and effective treatment in both the pregnant women and her fetus or newborn. Once dosing recommendations based on new biomarkers, pharmacometric approaches, and/or PBPK predictions have been validated in clinical trials, results can be incorporated in clinical