Table 1.

List of studies used for the development and qualification of the PBPK models in the current study.

Drug	Target	Age (Pediatric Population)	Number of individuals	Description and References
Palivizumab	RSV Protein F	Adults and children younger than 24 months	1,883(1756 children)	Population PK analysis using data from 22 clinical studies (Robbie et al., 2012)
		6.9 ± 1.3 months (3 mg/kg)#	10#	Phase I/II study in premature infants and infants with bronchopulmonary dysplasia (Subramanian et al., 1998)
		7.39 ± 2 months (10 mg/kg)	10
		8.19 ± 1.7 months (15 mg/kg)	22
		1.5 ± 0.4 months (5 mg/kg)#	8#	Phase I/II study in children with RSV infection (Saez-Llorens et al., 2004)
		5.2 ± 0.9 months (15 mg/kg)	22
Bevacizumab	VEGF-A	Adults	25 in 5 dose groups	Phase I study in cancer patients (Gordon et al., 2001)
		1–21 years, median, 13 years (total study)	20 total, 8 PK	Phase I study in pediatric cancer patients (Glade Bender et al., 2008)
		0.5–21 years, median, 10.8 years	152 for model building	Population PK analysis using data from cancer patients (5 studies) (Han et al., 2016b)

^#For the low dosages, only the reported PK parameters were used for comparison but not the concentration-time profiles, since they could not be read with sufficient accuracy from the published figure.