PK

PK Data Explained

Pharmacokinetics, or PK, is the monitoring of the concentration level over time of an analyte within a human (or animal) body. The analyte is typically an active ingredient of a drug, or an element such as sodium or potassium, or a chemical compound which occurs naturally in blood or other body fluids, such as creatinine or bilirubin. PK data collection for an active drug compound is performed routinely in all clinical trials since it is a critical part of measuring the safety and efficacy of an experimental treatment and in determining the treatment dose amount, frequency, and time-release profile…

A SAS® MACRO TO ADDRESS PK TIMING VARIABLES ISSUES

This paper discusses and lists a SAS® macro which addresses the challenge of evaluating timing variables and chronological sequencing for collected PK sampling and patient dosing data when sample and dose dates and times are not always recorded correctly on, or are omitted from, the case report form input. Examples of such datasets are PKS, POPPK, and NONMEM.
This macro is intended for use with the input data in CDISC format for a single dose per visit, with a single pre-dose sample and following post dose samples.