Delayed CSR preparation can result in the sponsor’s loss of considerable revenue each day the marketing application approval is delayed. Mistakes can cause the regulatory reader to question the validity of the content, and may lead to errors in interpretation. A good QC review takes time, but is well worth the effort. Real lives depend on us collectively to meet deadlines and to facilitate the process of getting life-saving drugs to market.
Just about everything from ballpoint pens to lima beans have their own “days” on the calendar each year. As statisticians, we feel that it goes without saying that statistics, the system of collecting, analyzing, interpreting, presenting, and organizing data, is far more deserving of recognition than ball point pens and lima beans! We are thrilled to be celebrating National Statistics Day today, and we honor the man for which this wonderful day is commemorated.
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.
The ADNCA dataset will adhere closely to the BDS structure. The dataset itself will contain a
combination of PK concentration data, its corresponding dosing data, and any additional data necessary to complete the non-compartmental analysis. The inclusion of this extra data is necessary, in part, because of the need to present timing variables related to the concentration event and dosing time. We will discuss the rationale for those timing variables as well as several other variables that are commonly of interest to the PK scientist.
In addition, the ADNCA data standard will support non-compartmental analyses, PK and PD data review, and could be utilized for tabular and graphical presentation of the data. However, ADNCA will not be suitable for population PK modeling analysis and is not intended to be used for presentation of the results of the PK analysis.
The ADNCA standard has been in development for some time and has gone through multiple rounds of revision. The ADaM sub-team has delivered a draft to the ADaM leadership team and the two continue to work together.
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.