§Please discuss the
ability of the proposed study to meet its objective of determining the relationship between body composition and daunomycin pharmacokinetics (PK).Specifically:
study will correlate body composition, size, age, gender, and ethnic background with daunomycin PK.Please identify any other patient or disease-specific factors for which PK
correlations should be made?
the study link the pharmacokinetic data with clinical and/or laboratory outcomes?If so, which outcomes would be most relevant?If
linkage to such outcomes is not appropriate or feasible in this study, should another study(ies) be conducted in
order to develop these
correlations?If so, please comment on
optimal study design(s).
discuss how the varied infusion regimens (infusions of any duration < 24 hours) could affect the interpretation
of any exposure-response
relationships for daunomycin.