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Glossary

Live Biotherapeutic Products (LBP)

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Biological products for the prevention, treatment, or cure of a disease or condition of human beings that contain live organisms, such as bacteria, and that are not vaccines

Other glossary definitions

I

Integrated summary of efficacy (or effectiveness) (ISE)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…

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A

Audit

A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively…

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