Posting the articles that Chris Latoz and Lori McCaig distributed to the Stability and Stats discussions - work of an IQ consortium team; Open access article.
Lean Stability Approaches in Pharmaceutical Product Development, Registration, and Post‑marketing CMC Change Management; Industry Survey Insights - Journal of Pharmaceutical Innovation, 2021
Lean Stability Case Studies-Leveraging Science- and Risk-Based Approaches to Enable Meaningful Phase Specific Pharmaceutical
Stability Strategies, Journal of Pharmaceutical Innovation, 2020
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Vinaya Kapoor, PhD
Vice President, Regulatory Affairs
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