Formulation
Age-appropriate formulation is required for pediatric studies. Per the
WR, the sponsors must develop and test an age-appropriate formulation if
one is not currently available. Special formulations have been developed
for several drugs in response to the WRs initiated since 2001, as shown
in TABLE 6 .
TABLE 5: Special formulations
developed in oncology pediatric trials in response to written requests
initiated since 2001.