Rezultaty - Kim Huynh-Ba

ANVISA: an introduction to a new regulatory agency with many challenges od Kim Huynh-Ba, Alexandra Beumer Sassi

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Stability considerations for drug-device combination products-21 CFR part 4 update od Christopher Latoz, Laure Larkin, Kim Huynh-Ba

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Stability challenges not addressed by harmonized guidance - AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD od Mohd M. Khan, Bowen Jiang, Anthony Mazzeo, Kim Huynh-Ba

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Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th,... od Kim Huynh-Ba, Greg Larner, Helen Strickland, Dilip Choudhury, Yan Wu, Jeff Hofer, Zhenyu Wang, Timothy Schofield

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Acceleration of new medicines-CMC lessons learned from emergency use authorizations od James Bernstein, Kim Huynh-Ba, Patrick Lynch, Thomas Oliver, Reza Oliyai, Scott W. Roberts, Andrea Schirmer, David Schwinke, Kin Tang, Jessica Ursin

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Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment od Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu, Yajie Zhang

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Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid od Marquerita Algorri, Ajay Acharya, James Bernstein, Nina S. Cauchon, Xiao Hong Chen, Kim Huynh-Ba, Carol Krantz, Tao Li, Yiwei Li, Sherita McLamore, Scott W. Roberts, David Schwinke, Rakhi Shah, Andrea Schirmer, Helen Strickland, Kin Tang, Timothy Watson

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