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Glossary

Clinical Impact

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The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.

Other glossary definitions

P

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license…

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C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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