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The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) | actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug. | approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication. |
| Volume of distribution at steady-state | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. |
| Terminal elimination rate constant (Ke) and Half-Life | Period of time that it takes for the concentration of the drug in the body to be reduced by on-half. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. |
| Plasma Clearance | the rate at which the drug is eliminated from the body divided by the plasma concentration. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. |
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Inclusion Criteria:
Exclusion Criteria:
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children < 8 years of age currently receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sneha Makhijani, BS | Contact | (984) 974-7865 | sneha_makhijani@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew M. Laughon, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina NC Children's Hospital | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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