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Glossary

Quality Overall Summary (QOS)

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An element of drug marketing applications, which provides a substantially condensed summary of the quality-related data provided within the submission.

 

Other glossary definitions

G

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…

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I

International Birth Date (IBD)

The date of the first marketing authorization for any product containing the active substance granted…

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