FDA’s June 2026 guide provides explicit SEND PC-domain handling for pharmacokinetic concentration results below the lower limit of quantitation (LLOQ).
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For below-LLOQ PC results, follow the guide’s PCORRES/PCSTRESC/PCSTRESN/PCSTRESU/PCLLOQ conventions and use SUPPPC PCCALCN only when a numeric substitute was assigned for group-summary calculations.
Key details
Core IssueFDA’s June 2026 guide provides explicit SEND PC-domain handling for pharmacokinetic concentration results below the lower limit of quantitation (LLOQ).
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
This page is limited to the SEND PC-domain below-LLOQ representation described in current FDA guidance; it is not a general bioanalytical reporting rule.
Purpose
For below-LLOQ PC results, follow the guide’s PCORRES/PCSTRESC/PCSTRESN/PCSTRESU/PCLLOQ conventions and use SUPPPC PCCALCN only when a numeric substitute was assigned for group-summary calculations.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
FDA’s June 2026 guide describes PC-domain timing/grouping details needed for SEND time-series use, including nominal timing relative to dose and information that identifies measurements within the exposure context.
In the June 2026 FDA Study Data Technical Conformance Guide, ASOCSTDY is the Trial Summary parameter code for Associated Study; FDA lists it as conditional for nonclinical Trial Summary data. FDA notes: include it if applicable. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
FDA’s June 2026 guide separates categorical noncontinuous laboratory results from numeric continuous results by using LBSTRESC, leaving LBSTRESN null, and documenting the categorical scale in the nSDRG.
For SEND laboratory data without published controlled terminology, FDA’s June 2026 guide says LBTESTCD values must follow the SENDIG constraints: no more than eight characters, not starting with a number, and using only letters, numbers, and underscores.
In the June 2026 FDA Study Data Technical Conformance Guide, STCAT is the Trial Summary parameter code for Study Category; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, SDESIGN is the Trial Summary parameter code for Study Design; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STDIR is the Trial Summary parameter code for Study Director; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
In the June 2026 FDA Study Data Technical Conformance Guide, STENDTC is the Trial Summary parameter code for Study End Date; FDA lists it as conditional for nonclinical Trial Summary data (when applicable). This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
