VOLUME 11, ISSUE 24 / DECEMBER 2019
White Paper
DECEMBER 2019
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,
- … See all authors
- Pages:2207–2244
- Published Online:10 December 2019
Special Report
DECEMBER 2019
Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2019
- Ryan Darling,
- Eric Bonner &
- Pei Li
- Pages:2245–2249
- Published Online:17 December 2019
Research Article
DECEMBER 2019
Application of multiplexed pharmacokinetic immunoassay to quantify in vivo drug forms and coadministered biologics
- Nicole Woodbury,
- Eric Bald,
- Brian Geist &
- Tong-Yuan Yang
- Pages:2251–2268
- Published Online:17 December 2019
Review
DECEMBER 2019
Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products
- Nazneen Bano,
- Troy McKelvey,
- Nathan Spear,
- Tong-Yuan Yang,
- Gopi Shankar &
- Allen Schantz
- Pages:2283–2296
- Published Online:17 December 2019
Review
DECEMBER 2019
Analytical techniques for metabolomic studies: a review
- Karen Segers,
- Sven Declerck,
- Debby Mangelings,
- Yvan Vander Heyden &
- Ann Van Eeckhaut
- Pages:2297–2318
- Published Online:17 December 2019