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Glossary

Assay

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(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure that determines the content of the drug substance.

 

Other glossary definitions

D

Device Deficiency

Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or…

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I

Identified risk

An untoward occurrence for which there is adequate evidence of an association with the medicinal…

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