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Glossary

Integrated summary of Safety (ISS)

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Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.

Other glossary definitions

D

Dysbiosis

Imbalance between the types/amounts of microorganisms present in a person’s natural flora, potentially leading to…

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L

Lay Person Summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of…

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