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Science and Risked-Based Stability Testing Strategies-a Test Case on the Global Implementation and Regulatory

Dorys Argelia Diaz1, Michael Lynch2, Megan McMahon3

  • 1Global Product Development- Global Regulatory Affairs- Global Manufacturing and Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA. dorys.argelia.diaz@pfizer.com.

The AAPS Journal
|October 26, 2020
PubMed

Keywords:
chemistry manufacturing and controls (CMC)drug productlean stabilityoral solid stabilityregulatoryscience and risk-based (SRB)shelf lifestabilitystability strategy

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