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Glossary

Anonymization Report (AR)

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Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.

Other glossary definitions

P

Potency

(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based…

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T

Target Product Profile (TPP)

Target product profile (TPP) in the US A TPP can be prepared by a sponsor…

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