A pharmacokinetic concentration-time dataset containing multiple dose administration data with specimen types (SERUM and URINE), dosing information, and subject demographics. This is an example dataset for demonstrating pharmacokinetic analysis workflows. It follows the ADaMIG-ADNCA v1.0 structure.
Format
A data frame with 76 rows and 32 variables:
- STUDYID
Character. Study identifier.
- USUBJID
Character. Unique subject identifier.
- PCSPEC
Character. Specimen type (SERUM or URINE).
- PARAM
Character. Parameter name (e.g., DrugA).
- METABFL
Character. Metabolite flag indicator.
- AFRLT
Numeric. Actual relative time to first dose (hours).
- NFRLT
Numeric. Nominal relative time to first dose (hours).
- ARRLT
Numeric. Actual relative time to reference dose (hours).
- NRRLT
Numeric. Nominal relative time to reference dose (hours).
- TRTRINT
Numeric. Treatment interval in hours.
- RRLTU
Character. Relative reference time units.
- AVAL
Numeric. Actual analysis value (concentration).
- AVALU
Character. Analysis value units (ug/mL or mg/mL).
- VOLUME
Numeric. Volume of specimen collected (mL for urine).
- VOLUMEU
Character. Volume units.
- DOSETRT
Character. Dose treatment identifier.
- TRT01A
Character. Actual treatment received (formatted dose and route).
- DOSEA
Numeric. Actual dose amount (mg).
- DOSEU
Character. Dose units.
- ROUTE
Character. Route of administration.
- ADOSEDUR
Numeric. Actual dose duration (hours).
- ATPTREF
Character. Analysis time point reference (e.g., DOSE 1).
- AGE
Numeric. Subject age.
- AGEU
Character. Age units.
- RACE
Character. Race/ethnicity of subject.
- SEX
Character. Sex of subject.
- NCA1XRS
Character. NCA result code 1 (if applicable).
- NCA2XRS
Character. NCA result code 2 (if applicable).
- NEFRLT
Numeric. Nominal relative time to first dose (alternative column).
- NERRLT
Numeric. Nominal relative time to reference dose (alternative column).
- AEFRLT
Numeric. Actual relative time to first dose (alternative column).
- AERRLT
Numeric. Actual relative time to reference dose (alternative column).
Details
This dataset contains pharmacokinetic data from multiple subjects receiving multiple dose regimens with different levels and routes of administration at 24-hour intervals. Concentration measurements are collected at multiple time points post-dose for both serum and urine samples. Analytes include parent drug and a metabolite.