C
Grade
Temozolomide
Some PK studies in children have been published, however, the number of infants was limited and the effect of age was not studied in most of the studies.
Level 1
Population PK model including infants
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Panetta (2003) | One compartment popPK model. BSA and age were included as covariates on CL and V. | 39 / NS | 7.1 (0.7-21.9) | Impact of increasing age and BSA on CL (L/h) and V (L). |
Level 2
PK model including infants or PopPK model without infants
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Wagner (2004) | One compartment popPK model | 12 / 0 | 12.5 (1-23) | Effect of age was not studied. | ||
| Broniscer (2005) | One compartment popPK model | 33 / 0 | 6.4 (3.1-15) | Effect of age was not studied. | ||
| Kirstein (2005) | One compartment popPK model | 38 / NS | NS | Effect of age was not studied. | ||
| Broniscer (2007) | One compartment popPK model | 44 / NS (Stratum 1) 26 / 0 (Stratum 2) | 8.6 (0.4-20.2) S1 11.3 (2.4-18.6) S2 | Effect of age was not studied. | ||
| Rubie (2010) | One compartment popPK model | 16 / 0 | 8.5 (3-19) | Effect of age was not studied. |
Level 3
Non-compartmental PK study or PK model without infants
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Riccardi (2003) | Non-compartmental pharmacokinetics | 22 (children) / 0 8 (adults) | 40 (3-16) / 30 (19-54), mean (range) | No effect of age on CL. BSA-normalized CL values comparable between children and adults. | ||
| Horton (2007) | Non-compartmental pharmacokinetics and compartmental PK model | 16 / 0 | 11 (1-19) | Effect of age was not studied. | ||
| Meany (2009) | Non-compartmental pharmacokinetics | 21 / 0 | 11.4 (3.0-21.3) | No effect of age on BSA-normalized CL |
