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收藏Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes
Mccaig, Lori; Nowak, Steven; Abbott, Alexander; Carhart, Jenny; Mcmahon, Megan E.; Debie, Elke; Li, Hanlin; Maina, Francis; Ji, Andrea J.; Fu, Mingkun; Wu, Yan; Lennard, Andrew; Mazzeo, Tony; Wolfe, Chad; Timpano, Robert; Babayan, Yelizaveta; Gruenig, Lars 分享 收藏 Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe -An EFPIA View动态监管评估: 拆包过程表明准备在欧洲进行试点-EFPIA观点Todd, Iain; Faust, Ruediger; Herrero-Martinez, Esteban; Hussain, Nasir; Kawinski, Adam; Lennard, Andrew; Le Roux, Nadege; Macdonald, Judith; Mayer, Mark; Palacios, Rodrigo; Dangy-Caye, Agnes 分享 收藏 Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and VaccinesPopkin, Matthew E.; Goese, Markus; Wilkinson, Diane; Finnie, Stuart; Flanagan, Talia; Campa, Cristiana; Clinch, Alexandra; Teasdale, Andrew; Lennard, Andrew; Cook, Graham; Mohan, Ganapathy; Osborne, Matthew D. 分享 收藏 The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data ManagementAhluwalia, Kabir; Abernathy, Michael J.; Beierle, Jill; Cauchon, Nina S.; Cronin, David; Gaiki, Sheetal; Lennard, Andrew; Mady, Pradeep; McGorry, Mike; Sugrue-Richards, Kathleen; Xue, Gang 分享 收藏 Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies (vol 23, 107, 2021)McMahon, Megan E.; Abbott, Alexander; Babayan, Yelizaveta; Carhart, Jenny; Chen, Chi-wan; Debie, Elke; Fu, Mingkun; Hoaglund-Hyzer, Cherokee; Lennard, Andrew; Li, Hanlin; Mazzeo, Tony; McCaig, Lori; Pischel, Sylvine; Qiu, Fenghe; Stephens, Dennis; Timpano, Robert; Webb, Debra; Wolfe, Chad; Woodlief, Kayla; Wu, Yan 分享 收藏 Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment StrategiesMcMahon, Megan E.; Abbott, Alexander; Babayan, Yelizaveta; Carhart, Jenny; Chen, Chi-wan; Debie, Elke; Fu, Mingkun; Hoaglund-Hyzer, Cherokee; Lennard, Andrew; Li, Hanlin; Mazzeo, Tony; McCaig, Lori; Pischel, Sylvine; Qiu, Fenghe; Stephens, Dennis; Timpano, Robert; Webb, Debra; Wolfe, Chad; Woodlief, Kayla; Wu, Yan 分享 收藏 Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology IndustriesRoberts, Scott W.; Lennard, Andrew; Mohan, Ganapathy; Bernstein, James; Cauchon, Nina S.; Cole, Steve; Curristin, Noreen; Huynh-Ba, Kim; Kolz, Christine N.; Murti, Cheenu; Tang, Kin 分享 收藏 
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