Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by
 their treating caregiver and only biological sample collection during the time of drug
 administration will be involved. A total of approximately 7000 children aged <21 years who
 are receiving these drugs for standard of care will be enrolled and will be followed for up a
 maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of
 understudied drugs for which specific dosing recommendations and safety data are lacking. The
 prescribing of drugs to children will not be part of this protocol. Taking advantage of
 procedures done as part of routine medical care (i.e. blood draws) this study will serve as a
 tool to better understand drug exposure in children receiving these drugs per standard of
 care. The data collected through this initiative will also provide valuable pharmacokinetic
 and dosing information of drugs in different pediatric age groups as well as special
 pediatric populations (i.e. obese).
The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs
 administered to children per standard of care as prescribed by their treating caregiver. This
 will be accomplished by the collection of biological samples during the time of drug
 administration per standard of care as prescribed by the caregiver. The prescribing of drugs
 to children will not be part of this protocol.

 Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

 Hypothesis #1: The PK of understudied drugs in children will differ from adults and within
 children according to pediatric age groups or special population.

 Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered
 to children.

 Hypothesis #2: The PD of targeted drugs in children will differ from adults.

 Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on
 therapeutic exposure.

 Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic
 profiles will impact drug exposure in children.
Inclusion Criteria:

 -  1) Children (< 21 years of age) who are receiving understudied drugs of interest per
 standard of care as prescribed by their treating caregiver

 Exclusion Criteria:

 -  1) Failure to obtain consent/assent (as indicated)

 -  2) Known pregnancy as determined via interview or testing if available.