Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
|Articles|June 2, 2003
- Pharmaceutical Technology-06-02-2003
- Volume 27
- Issue 6
From Genome Exploration to Drug Development
Author(s)Jill Wechsler
FDA's plan to establish pharmacogenomic policies spurs concerns among manufacturers, particularly in regard to how the policies will affect new-drug testing and approval.
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