Outsourced Pharma Covers this 2025 ISPE Annual Meeting & Expo Presentation on a Novel Approach to Stability from Pfizer Experts
Two 2025 ISPE Annual Meeting & Expo speakers, Jennifer Brown, Senior Director, Global Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) with Pfizer and Lina Niu, Associate Director, Statistics with Pfizer, presented “Gazing into the Crystal Ball of Stability.” In the article that follows, they outlined the novel statistical approach to stability that they presented at the conference and discussed the purpose of Pfizer’s Accord for a Healthier World program, which aims to address healthcare disparities in lower income countries. Brown and Niu, along with their colleague Paul Gerst, Senior Principal Scientist with Pfizer, explain the program and describe how their statistical approach accounts for the higher temperatures and humidity conditions that many lower income countries experience, how they are balancing prediction model innovation with the need for global regulatory acceptance, and more.
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Outsourced Pharma is part of the Life Science Connect media group. The publication provides in-depth content from experts in the field of pharmaceutical outsourcing.