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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

E

Expectedness

An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described…

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C

Critical Quality Attribute (CQA)

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate…

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