SENDIG v3.1.1

Published Date:

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 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

Public Review Comments

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