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What goes into the Investigator’s Brochure?

BayBiotech.NET
As per ICH guidelines, the overall aim of an Investigator’s Brochure is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of specific tests, observations and precautions that may be needed to conduct a clinical trial maintaining the safety of the patients enrolled for the study. This information must be based on scientific data produced by performed physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information of the investigational drug or device. Based on the scientific studies, the Investigator’s Brochure is intended to provide the Investigator with necessary management of study subjects throughout the clinical trial. Main focus must be given to the following measures:
A. Dose
B. Frequency of the dose
C. Method of administration
D. Safety monitoring procedures
E. List of abbreviations and acronyms
F. Description of the formulation of the drug
G. Instructions for the storage

Reference:
ICH Topic E 6 (R1) Guideline for Good Clinical Practice

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