Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4

Document information
Reference	ICH ICH E6 Guideline R3 (2025)
Validity area	ICH
Scope(s)	HM
Document name	ICH E6 Guideline
Version / Revision	R3 (2025)
Status	Current
Document type	International guideline
Language(s)	EN
Description	GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.4.1
Scope	G
Document part	Appendix A 3.4
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Investigator's brochure, Investigational drug (IMP), IMP storage, Manufacturing

Content

A.3 Contents of the Investigator’s Brochure [...] A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)), and a brief summary should be given of the relevant physical, chemical and pharmaceutical properties.

To permit appropriate safety measures to be taken in the course of the trial, a description of the formulation(s) to be used, including excipients, should be provided and justified if clinically relevant. Instructions for the storage and handling of the dosage form(s) should also be given.

Any structural similarities to other known compounds should be mentioned.