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Glossary

Development international birth date (DIBD)

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Date of first approval (or authorization) for conducting an interventional clinical trial in any country (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Other glossary definitions

A

Assay

(For Small Molecule and Synthetic Low Molecular Weight Peptide Drug Substances) A specific, stability-indicating procedure…

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C

Competent Authority

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines…

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