This paper will give a preview of the soon to come non-compartmental pharmacokinetic analysis CDISC ADaM standard (ADNCA). ADNCA will be the submission data set that is sent to the PK scientist for calculation of non-compartmental PK parameters. We will present the proposed guidance and give an overview of the steps involved in developing this standard for analysis and submission to the FDA.
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.
In Part 1, we will discuss a general overview of how Pharmacokinetics and Pharmacodynamics (PK/PD) plays a key role with 3 key stakeholders: Patients, Drug Companies, and the Federal Drug Administration.