ICH E3 section 9.4.4 calls for the report to explain how doses used in the study were selected within the treatment plan. Keep dose-selection rationale separate from section 9.4.5, which addresses how dose and dosing time were selected for individual patients.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Explain the basis for selecting the study dose or dose range, including relevant prior information or study-design considerations needed to understand that choice.
Key details
Core IssueICH E3 section 9.4.4 calls for the report to explain how doses used in the study were selected within the treatment plan.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
Keep dose-selection rationale separate from section 9.4.5, which addresses how dose and dosing time were selected for individual patients.
Further guidance
Content
Explain the basis for selecting the study dose or dose range, including relevant prior information or study-design considerations needed to understand that choice.
Purpose
Explain the basis for selecting the study dose or dose range, including relevant prior information or study-design considerations needed to understand that choice.
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 9.4.5 addresses rules or methods used to select the dose and timing of dose for individual patients. This is the patient-level dosing procedure subsection, not the preceding rationale for selecting the study doses or the later results analysis of dose-response relationships.
ICH E3 section 9.3 identifies Selection of Study Population as the investigational-plan section that frames how the study population was selected and leads into inclusion, exclusion, and removal criteria. This is the ICH E3 investigational-plan population-selection section, not the later results description of who was actually enrolled or their demographic/baseline characteristics.
ICH E3 section 12.3.3 calls for analysis and discussion across deaths, other serious adverse events, and other significant adverse events after the relevant case listings and narratives. This is an interpretive synthesis, not a duplicate death/serious-event listing or a replacement for individual patient narratives.
ICH E3 section 12.2.3 calls for analysis of adverse events beyond their tabular display, focusing on patterns important to safety interpretation. Do not treat the analysis as a substitute for the event display or patient-level listing, and do not imply causality beyond what the study evidence supports.
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 12.2.1 calls for a brief summary of adverse events within the safety evaluation before more detailed displays and analyses. Keep this section a high-level summary; it is not a substitute for detailed adverse-event displays, patient-level listings, serious-event treatment, or narratives.
ICH E3 section 9.8 calls for changes made after the study began to the conduct of the study or planned analyses to be described, including timing, reasons, decision process, responsibility, available data, and interpretive implications as applicable. This section is broader than a statistical-methods subsection: it covers material study-conduct changes as well as planned-analysis changes, while detailed statistical methods remain in their dedicated section.
ICH E3 section 9.2 calls for discussion of the chosen control and study design, including design problems or biases that may matter for interpretation. This guide concerns the rationale and limitations of the control/design choice; the Study Design guide owns the descriptive overview of the study configuration itself.
