C
Grade
Cytarabine
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 | ||
|---|---|---|---|---|---|---|
| Periclou (1996) | Two compartment popPK model (ARA-C). One compartment popPK model (ARA-U) | 52 / NS | NS (0.2-19) | All parameters increase with increasing age and BSA. Conversion of ARA-C to ARA-U is age dependent (lower rate of conversion in infants). |
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 | ||
|---|---|---|---|---|---|---|
| McLeod (1992) | One compartment PK model | 67 / 3 | NS (0.64-19) | CL (mL/min/m2) is not different in infants. |
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 | ||
|---|---|---|---|---|---|---|
| Avramis (1987) | Non-compartmental pharmacokinetics (ARA-C and ARA-U) | 20 / 0 | 3 (1.5-19) | AUC (ARA-C) higher in children compared to adults. Patients <2 yrs had higher ARA-C concentrations than older patients | ||
| Avramis (1989) | Two compartment PK model (ARA-C). One compartment PK model (ARA-U). Age and BSA were included as covariates on all parameters. | 8 / 1 | 6.5 (0.58-16) | Age was included as covariate on all parameters. | ||
| Avramis (1998) | Non-compartmental pharmacokinetics (ARA-C) | 20 / 0 | 8 (1-19) | Effect of age was not studied. | ||
| Evans (1998) | One compartment PK model | 182 / 8 | NS (0.3-18.8) | Effect of age was not studied. | ||
| Ozkaynak (1998) | Non-compartmental pharmacokinetics (ARA-C and ARA-U) | 13 / 0 | 7 (1-17) | Effect of age was not studied. |
