The draft of version 3.1.1. of the Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (SENDIG) is available for Public Review.
SENDIG v3.1.1 introduces revisions to the Pharmacokinetic Concentrations (PC) Domain and the Pharmacokinetic Parameters (PP) Domains focused on providing instruction and examples to improve standardization of these data, especially timing variables, for more consistent use by data consumers (e.g., use in creation of Time/Concentration Curves). This includes changes to the expectancy or "Core" value for some timing variables. New examples are provided to show the relationship between concentration data and their relevant parameters. Cross-domain examples now show how the domains EX, PC, PP, SUPPPC and POOLDEF work together for a study. Examples include how best to represent an unscheduled concentration sample, as well as different ways of qualifying AUC tests.
SENDIG v3.1.1 provides:
- The exact minimum combination of variables needed to create the Time/Concentration Curve, noting that other timing variables are still useful and should be populated if at all possible
- Commentary on populating these variables
- Well-formed examples for PC and PP domains
The document includes an appendix Revision History that details every change from SENDIG v3.1 to SENDIG v3.1.1.
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View the draft: SENDIG v3.1.1
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