Glossary

Investigator’s Brochure (IB)

The Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Includes a description of the drug formulation, a summary of toxicological and pharmacological effects, a summary of safety and effectiveness, and a description of possible risks and side effects. The IB must be updated whenever there is relevant new information about the drug.

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Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.