Drug Concentration Measurements in Clinical Study Report
ICH E3 section 9.5.4 identifies drug concentration measurements as a distinct investigational-plan subsection when such measurements are part of the study. This methods subsection is distinct from patient-level laboratory-data listings and from later analyses relating dose or concentration to clinical response.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Describe planned drug-concentration sampling and measurement information needed to understand when, how, and for what study purpose concentrations were assessed.
Key details
Core IssueICH E3 section 9.5.4 identifies drug concentration measurements as a distinct investigational-plan subsection when such measurements are part of the study.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This methods subsection is distinct from patient-level laboratory-data listings and from later analyses relating dose or concentration to clinical response.
Further guidance
Content
Describe planned drug-concentration sampling and measurement information needed to understand when, how, and for what study purpose concentrations were assessed.
Purpose
Describe planned drug-concentration sampling and measurement information needed to understand when, how, and for what study purpose concentrations were assessed.
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.
ICH E3 section 11.4.4 addresses relationships among dose, measured drug concentration, and clinical response when those data are relevant to interpreting efficacy. This results-level relationship analysis is distinct from documenting how doses were selected or how concentrations were measured during study conduct.
ICH E3 section 9.5.2 calls for discussion of the appropriateness, reliability, or relevance of measurements used to assess efficacy and safety when explanation is needed. This subsection justifies or qualifies measurement choices; it does not replace the section that defines the variables, methods, and timing of assessments.
ICH E3 section 11.4.5 calls for efficacy discussion of drug-drug and drug-disease interactions when they are relevant to the study findings. Do not turn the subsection into a general pharmacology interaction catalogue; keep it tied to interactions evaluated or observed in the reported clinical study.
ICH E3 appendix 16.2.8 addresses listings of individual laboratory measurements by patient when such listings are required by regulatory authorities. ICH E3 makes these patient-level listings conditional on regulatory requirements; this page does not imply that every CSR must include the same laboratory appendix.
ICH E3 section 12.4.1 points to a by-patient listing of abnormal laboratory values in section 14.3.4 and distinguishes that safety display from the broader listing of individual laboratory measurements. This page is about the dedicated abnormal-value listing under ICH E3 14.3.4; it is distinct from the full individual-measurement appendix under 16.2.8 and from analytical discussion in section 12.4.2.
ICH E3 section 11.4.2.7 identifies special efficacy-analysis considerations for active-control studies intended to support equivalence. This is a CSR efficacy-results reporting issue for active-control equivalence designs; it does not define a universal equivalence margin or replace protocol-level design justification.
ICH E3 section 11.4.2.1 calls for covariate or prognostic-factor selection and adjustment to be explained, including adjustment methods, analysis results, supportive statistical documentation, and differences from planned analyses when relevant. This results-stage statistical issue is narrower than the general statistical-methods section and should not be used as a substitute for documenting the full analysis plan.
ICH E3 places patient-level adverse-event listings in the report appendices and calls for listings that identify individual patients and relevant event details supporting review. A listing is not the same as a summary adverse-event table or a selected patient narrative; each serves a different level of safety reporting.
