Drug | Route of Administration | Objective(s) | Software | Data Used in Model Build | Performed Prior to FTPa | Reference |
---|---|---|---|---|---|---|
Busulfan | i.v. | Predict plasma concentration-time curves | PK-Sim (Bayer Technology Services, Germany) | Adult | No | Diestelhorst et al., 2014 |
Cisplatin | i.v. | Describe the PBPK model development; simulate cisplatin disposition in humans | Not reported | Dog | No | Evans et al., 1982 |
Docetaxel | i.v. | Demonstrate how PBPK modeling can be applied to optimize dose and sampling times for a pediatric PK bridging study in oncology | Simcyp (Certara, UK) | Adult | No | Thai et al., 2015 |
Etoposide | i.v. | Evaluate the ability of PBPK to predict the systemic drug exposure in children and the effect of comedications | PK-Sim | Adult | Kersting et al., 2012 | |
Imatinib | p.o. | Predict plasma concentration-time profiles in plasma and tissue in pediatric subjects, and assess the effect of pediatric growth processes using a PBPK model | Not reported | Adult | No | European Medicines Agency, 2013 |
Evaluate factors influencing imatinib exposure in pediatric patients | ||||||
6-Mercaptopurine | i.v. and p.o. | Improve dose individualization and dosage regimen optimization; model DDI interaction with methotrexate | MATLAB (Mathworks, Natick, MA) | Adult | No | Ogungbenro et al., 2014b |
Methotrexate | i.v. and p.o. | Evaluate the role of modeling and simulation in the development of drugs for rare diseases | MATLAB | Adult | No | Ogungbenro et al., 2014a |
Methotrexate | i.v. | Evaluate the effect of malignant effusions on the PK of methotrexate | Berkeley Madonna (University of California–Berkeley, Berkeley, CA) | Adult | No | Li and Gwilt, 2002 |
Obatoclax | i.v. | Evaluate the potential to achieve target exposures in infants | PK-Sim | Mouse | Yes | Barrett et al., 2011 |
Pinometostat | i.v. | First-time-in-pediatrics starting dose selection | Simcyp | Adult | Yes | Waters et al., 2014 |
Tazemetostat | p.o. | First-time-in-pediatrics starting dose selection | GastroPlus (Simulations Plus, Lancaster, CA) | Adult | Yes | Rioux et al., 2015 |
↵a First time in pediatrics.