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Glossary

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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

Development international birth date (DIBD)

Date of first approval (or authorization) for conducting an interventional clinical trial in any country…

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A

Anonymization

The process of rendering data into a form which does not identify individuals and where…

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