2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Brian Booth,Lauren Stevenson,Renuka Pillutla,Michael H. Buonarati,Chris Beaver,Daniela Fraier,Fabio Garofolo,Sam Haidar,Rafiq Islam,Christopher A. James,John Kadavil,Olga Kavetska,Fumin Li,Christina Satterwhite,Natasha Savoie,Sriram Subramaniam,Nilufer Tampal,Theingi Thway,Eric Woolf,Olivier Le Blaye,Matthew Andisik,Chad Briscoe,Stephanie Cape,Arindam Dasgupta,Sally Fischer,Roger Hayes,John Kamerud,Gustavo Mendes Lima Santos,Corey Nehls,Catherine Soo,Stephen Vinter,Emma Whale,Keyang Xu,Seongeun (Julia) Cho,Anna Edmison,Sean Kassim,Thais Rocha,Jan Welink,Shashi Amur,Abbas Bandukwala,Elana Cherry,Shirley Hopper,Akiko Ishii-Watabe,Susan Kirshner,Kevin Maher,João Pedras-Vasconcelos,Yoshiro Saito,Therese Solstad Saunders,Venke Skibeli,Daniela Verthelyi,Yow Ming Wang,Haoheng Yan

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

2019

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical c...

Keywords:

White paper
Bioanalysis
Biopharmaceutical
Medical physics
Chemistry
Guideline
Chromatography

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