Article thumbnail

Modelling and simulation as research tools in paediatric drug development

By Francesco Bellanti and Oscar Della Pasqua
Topics: Review Article
Publisher: Springer-Verlag
OAI identifier: oai:pubmedcentral.nih.gov:3082698
Provided by: PubMed Central

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.

Suggested articles

Citations

  1. (2010). A model-based approach to dose selection in early pediatric development.
  2. (2007). A quantitative approach to benefit-risk assessment of medicines. I. The development of a new model using multi-criteria decision analysis.
  3. (2003). ADMET in silico modelling: towards prediction paradise. Nat Rev Drug Discov 2:192–204
  4. (2009). Analysis of the relationship between age and treatment response in migraine.
  5. (2007). Applications of population pharmacokinetics in current drug labelling.
  6. (2003). Biomarkers in drug discovery and development: from target identification through drug marketing.
  7. (2002). Clinical Trial Simulation of a 200-μg Fixed Dose of Darbepoetin Alfa in Chemotherapy-Induced Anemia. Oncology 16(Suppl 11):
  8. (2005). Clinical trial simulation: a tool for understanding study failures and preventing them. Basic Clin Pharmacol Toxicol 96:228–234
  9. (2009). Continual reassessment method vs. traditional empirically based design: modifications motivated by phase I trials in pediatric oncology by the Pediatric Brain Tumor Consortium.
  10. (2008). Evaluation of drugs in pediatrics using K-PD models: perspectives. Fundam Clin Pharmacol
  11. (2009). From trial and error to trial simulation. I. The importance of modelbased drug development for antidepressant drugs.
  12. (2001). ICH topic E11: clinical investigation of medicinal products in the paediatric population.
  13. (2008). Improving pediatric dosing through pediatric initiatives: what we have learned.
  14. (2005). Improving predictive modeling in pediatric drug development: pharmacokinetics, pharmacodynamics, and mechanistic modeling.
  15. (2008). Integration of modelling and simulation into the development of intravenous busulfan in paediatrics: an industrial experience.
  16. (2009). Knowledge of developmental pharmacology and modeling approaches should be used to avoid useless trials in children.
  17. (2008). Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research.
  18. (2008). Minutes from the round table held in Paris on
  19. (2007). Model-based drug development.
  20. (2009). Modelling and PBPK simulation in drug discovery.
  21. (2001). Modelling and simulation in clinical drug development. Drug Discov Today 6:802–806
  22. (2005). Modelling approaches to dose estimation in children.
  23. (2001). Oral glucose tolerance test minimal model indexes of beta-cell function and insulin sensitivity.
  24. (2010). Pediatric dose selection.
  25. (2009). Pharmacodynamic modelling of rocuronium in adolescents with Duchenne muscular dystrophy.
  26. (2008). Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modelling. Fundam Clin Pharmacol
  27. (2002). Pharmacokinetics and effects of propofol 6% for shortterm sedation in paediatric patients following cardiac surgery.
  28. (2008). PK/PD modelling and simulations: utility in drug development.
  29. (2008). Population approaches in paediatrics.
  30. (2006). Population clinical pharmacology of children: general principles.
  31. (2005). Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis.
  32. (2008). Population pharmacokinetics and dose simulation of carvedilol in paediatric patients with congestive heart failure.
  33. (2008). Population pharmacokinetics of oral diclofenac for acute pain in children.
  34. (2005). Predictive biosimulation and virtual patients
  35. (2010). Quantification of apixaban’s therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.
  36. (2009). Quantitative Disease, Drug and Trial Models.
  37. (2002). Small- and large-scale biosimulation applied to drug discovery and development.
  38. (2010). Systems biology from micro-organisms to human metabolic diseases: the role of detailed kinetic models.
  39. (2009). Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today 14:316–320
  40. (2006). The impact of systems biology and biosimulation on drug discovery and development.
  41. (2009). The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy.
  42. (2007). The nature of systems biology.
  43. (2008). Use of oral glucose minimal model-derived index of insulin sensitivity in subjects with early type 1 diabetes mellitus.
  44. (2003). Utility of physiologically based pharmacokinetic models to drug development and rational drug discovery candidate selection.
  45. (2004). Utilization of juvenile animal studies to determine the human effects and risks of environmental toxicants during postnatal developmental stages.
  46. (2001). van Peer A
  47. (2010). What is the right dose for children?