To better understand Pharmacokinetic (PK) CDISC standards, the requirements surrounding PK CDISC standards, and how Nuventra can assist your team in complying with CDISC standards, we have created a two-part blog on everything you need to know about CDISC. Below are 6-10 of the 10 Things to Know About CDISC Blog:
6. What are the PK CDISC Standards?
CDISC uses three major data standards: SEND for nonclinical data, SDTM for clinical data, and ADaM for analysis ready data. You can find definitions and more general information on these three standards below in numbers 8, 9 & 10.
PK and CDISC: Within CDISC, PK data are highly specialized. In the SDTM and ADaM PK domains (see what are CDISC domains? #7), clinical and bioanalytical data have to be reconciled. In SEND, SDTM, and ADaM, PK parameters are generated, and specialized domains are created to show the exact relationship between the raw data and calculated parameters.
7. What are CDISC Domains?
SEND, SDTM, and ADaM data are all organized into domains. A domain is an individual dataset that contains a specific grouping of data. The relevant pharmacokinetic (PK) domains for SEND and SDTM are the PC domain which stands for pharmacokinetic concentrations, the PP domain which stands for pharmacokinetic parameters, and the RELREC domain which stands for related records. The relevant ADaM PK domains are the ADPC and the ADPP, which can be used for pharmacokinetic analyses.
- PC: Data collected about tissue (e.g., serum or plasma) concentrations of analytes (usually study drugs and/or their metabolites) as a function of time after dosing the study drug.
- PP: Data describing the pharmacokinetic parameters of the time-concentration curve for PC data (e.g., area under the curve all, maximum concentration, time of maximum observed concentration sampled during a dosing interval).
- RELREC: Data that relates the exact pharmacokinetic concentrations from the PC dataset to the resulting pharmacokinetic parameters in the PP dataset.
- ADPC: Analysis ready data collected about tissue concentrations of analytes as a function of time. This dataset may contain additional information to the SDTM PC domain, including calculations of elapsed times and imputations of values below the lower limit of quantification.
- ADPP: Analysis ready data describing the parameters of the time-concentration curve for PC data. This dataset may contain additional information to the SDTM PP dataset, including flags for values to be used in further analyses, such as bioequivalence.
8. What is SEND?
SEND stands for “Standard for the Exchange of Non-clinical Data.” SEND guides the organization, structure, and format of all nonclinical data, which is data from cell cultures and animals. The SEND Implementation Guide (SEND-IG) provides predefined domains and examples of nonclinical (animal) data based on the structure and metadata defined by the SDTM. The current Standard Exchange of Nonclinical Data Implementation Guide (SENDIG), version 3.0, is designed to support single-dose toxicology, repeat‑dose toxicology, and carcinogenicity studies. Future versions that cover reproductive and safety pharmacology study designs are in development.
9. What is SDTM?
SDTM stands for “Study Data Tabulation Model.” SDTM is arguably the most well recognized and widely implemented CDISC standard. SDTM outlines a universal standard for how to structure and build content for data sets for individual clinical study data (which is data collected from humans). The SDTM Implementation Guide (SDTM-IG) gives a standardized, predefined collection of domains for clinical data submission, each of which is based on the structure and metadata defined by the SDTM. SDTM data are raw data, and often need further modification before the data are analysis ready.
10. What is ADaM versus SDTM?
ADaM stands for “Analysis Data Model.” ADaM can also be thought of as data that is “analysis ready.” The main difference between ADaM and SDTM standards are the way in which the data is displayed. SDTM provides a standard for the creation and mapping of collected data from raw sources, whereas ADaM provides a standard for the creation of analysis-ready data, often using SDTM data as the source. ADaM datasets can be used by the FDA to easily recreate analyses.
Are You CDISC Ready?
As a CDISC Gold Member, our CDISC experts at Nuventra are actively involved in all forms of PK CDISC standards and implementation. Make your pharmacokinetic SEND, SDTM, and ADaM datasets work with your CRO to ensure proper implementation of PK CDISC.
How Can Nuventra Help?
Nuventra has been an industry leader with regards to PK CDSIC standards by serving on the ADaM Working Group and PK Cross Functional Team. As a CDISC Gold Member, our CDISC experts are actively involved in all forms of PK CDISC standards and implementation. Make your pharmacokinetic SDTM, ADaM, and SEND datasets work with your CRO to ensure proper implementation of PK CDISC.
Nuventra can help by:
- Generating PK datasets for legacy, planned, and current studies
- Working with your CRO on CDISC implementation
- Providing advice for FDA submissions
Want to know more about CDISC?
Read Part 1 of our CDISC Blog: 10 Things to Know About CDISC: General Information and Important Dates
What should you do now?
Click here, or call 888.615.5111 today, to contact a member of our expert CDISC team to learn more about CDISC and to see if your datasets are in compliance with the FDA’s soon-to-be required CDISC Standards.