2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Steven Piccoli,Devangi Mehta,Alessandra Vitaliti,John Allinson,Shashi Amur,Steve Eck,Cherie Green,Michael Hedrick,Shirley Hopper,Allena Ji,Alison Joyce,Virginia Litwin,Kevin Maher,Joel Mathews,Kun Peng,Afshin Safavi,Yow-Ming Wang,Yan Zhang,Lakshmi Amaravadi,Nisha Palackal,Sai Thankamony,Chris Beaver,Eris Bame,Thomas Emrich,Christine Grimaldi,Jonathan Haulenbeek,Alison Joyce,Vellalore Kakkanaiah,David Lanham,Kevin Maher,Andrew Mayer,Paul C Trampont,Laurent Vermet,Naveen Dakappagari, Catherine Fleener,Fabio Garofolo, Cynthia Rogers,Shabnam Tangri,Yuanxin Xu,Meina Liang,Manoj Rajadhyaksha,Susan Richards,Becky Schweighardt,Shobha Purushothama,Daniel Baltrukonis,Jochen Brumm,Elana Cherry,Jason Delcarpini,Carol Gleason,Susan Kirshner,Robert Kubiak,Luying Pan,Michael Partridge,João Pedras-Vasconcelos,Qiang Qu,Venke Skibeli, Therese Solstad Saunders,Roland F Staack,Kay Stubenrauch, Al Torri,Daniela Verthelyi,Haoheng Yan,Boris Gorovits,Rachel Palmer,Mark Milton,Brian Long,Bart Corsaro,Vahid Farrokhi,Michele Fiscella,Neil Henderson,Vibha Jawa,Jim McNally,Rocio Murphy, Hanspeter Waldner,Tong-Yuan Yang BIOANALYSIS（2019）
关键词
fda immunogenicity guidance,gene therapy bioanalytical challenges,flow cytometry validation,biomarkers assay validation,flow cytometry
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