FDA regulations [21 CFR 312.23 (5)] state that an Investigator's Brochure must contain the following information:
- A brief description of the drug substance and the formulation.
- A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
- A summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.
- A summary of information relating to safety and effectiveness in humans obtained from prior clinical studies.
- A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and or precautions or special monitoring to be done as part of the investigational use of the drug.
ICH Good Clinical Practice Guidelines for an Investigator's Brochure
THIS IS A VERY LARGE FILE PLEASE DO NOT OPEN IF YOU DO NOT HAVE 150MB AVAILABLE RAM - Investigator's Brochure Example Document
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