Pk/PD Data is Critical

The PK/PD data you collect plays a critical role in the success or failure of your FDA submission, and ultimately the approval of your drug. Once approved, patients and providers will depend on the accuracy of PK/PD information because they both play a key role in the success or failure of the drug treatment. Contact us to learn more.

 

We are PK/PD Data Experts

It takes an average of 12 years for an experimental drug to travel from the laboratory to the consumer. Only 5 out of 5000 drugs that enter the preclinical testing program progress to human trials, and only one out of 5 drugs are approved by the FDA.

By using a set of established guidelines for the collection, assimilation, and transfer of millions of datasets, the FDA can process and compare that information with other datasets. Standards allow the FDA to make an informed decision to both protect the public health of consumers and enable life-saving and life-enhancing drugs to be brought to market as quickly and efficiently as possible.

PK/PD Process

The success of a clinical trial - and your FDA submission - depends heavily on the standardization and harmonization of the many data points used in the study. The only way to achieve this from so many different sources is with specific programming tools managed by highly skilled individuals with years of experience and CDISC expertise.

 
 

DataCeutics Transforms PK/PD Data into Meaningful, Standards-Compliant Tables, Listings and Graphs for FDA Submission

PK data arrives from multiple sources, sometimes using different standards. The results of the analysis must be standardized and stored as SAS® datasets using standard CDISC compliant structure. In some cases, units of measurement are different and affected results must be converted and labeled with the standard units.

Our industry-leading clinical SAS programmers have years of experience managing and transforming PK/PD trial data into CDISC compliant tables, listings, and graphs for successful FDA submission. Our QA team and project managers are dedicated to your project. Our team will make sure your deliverables arrive on time, on budget, and error-free.

 
 

DataCeutics Remains Current on the Emerging CDISC ADNCA Standards for PK/PD Data

There is currently a gap in the SDTM and ADaM standards for handling and formatting data to allow for non-compartmental PK parameter calculations. The data that is required for PK parameter software is a combination of several datasets. Therefore, an SDTM convention like PC (Pharmacokinetic Concentrations) would not meet the necessary requirements for this analysis. In addition, the required data structure is more complicated than the currently defined ADaM BDS structure.

New ADNCA & PK Submission Guidelines
 

As a result, the ADaM leadership team formed a sub-team tasked with the creation of a new set of specifications specifically for this situation. The end goal of this sub-team was to develop standards that closely follow current ADaM guidance while allowing flexibility to work with various types of software packages used to analyze PK data.

ADNCA is the result of this sub-teams’ effort. ADNCA is still in review following the development process for CDISC standards. DataCeutics is closely following the development of this much-needed new standard. When it is released, our programming team will be ready to lead the industry.