Pharmacometrics
Case Studies |
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Results: Timely NDA Submission
In order to meet an aggressive NDA submission date, over 100,000 vital signs data points — from a Phase I pharmacodynamic study in 150 subjects — were entered, validated and queried. The subsequent 7,000-page fully integrated study report was issued 16 days after database lock, with Covance finalizing the report at the client's headquarters less than one week later. |
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