Investigator's brochure (IB)

In Documents & records

The investigator's brochure is the sponsor's summary of everything known so far about the investigational product. It covers its chemistry, how it behaves in the body, the results of earlier studies, and the risks seen to date. It is the reference used to judge whether a new side effect is expected or unexpected.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.