(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure that determines the content of the drug substance.
(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure that determines the content of the drug substance.
Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or…
View definitionAn untoward occurrence for which there is adequate evidence of an association with the medicinal…
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