VOLUME 16, ISSUE 5 / MARCH 2024
White Paper
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 – keeping our finger on the pulse
- Philip Timmerman,
- Matthew Barfield,
- Enric Bertran Portabella,
- Salvatore Calogero,
- Kyra Cowan,
- Jörg Faber,
- Luca Ferrari,
- Michaela Golob,
- Jo Goodman,
- Lee Goodwin,
- Mark Jean Gnoth,
- Richard Hughes,
- Tsvetelina Ivanova,
- Gregor Jordan,
- Anna Laurén,
- Delphine Maux,
- Stuart McDougall,
- Petya Milushewa,
- Robert Nelson,
- Gwenda Pynaert,
- Kamil Sklodowski,
- Rebecca Sleigh,
- Petra Struwe,
- Tom Verhaeghe,
- Robert Wheller,
- Steve White &
- Katja Zeiser
Commentary
march 2024
Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics
- Pages:271–275
- Published Online:14 MARCH 2024
Methodology
MARCH 2024
Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics
- Rodd Polsky
, - George Gunn,
- Kimberly J Reese,
- Charles Scott Hottenstein,
- Andrew Gehman,
- Ann Schwartz,
- Devin Root &
- Amy Concannon
- Pages:277–287
- Published Online:13 MARCH 2024
Research Article
MARCH 2024
A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood
- Ruiqi Liu,
- Xiaojie Li,
- Yingyi Liu,
- Lijun Du,
- Yingzhu Zhu,
- Lichuan Wu &
- Bo Hu
- Pages:289–303
- Published Online: 13 MARCH 2024
Research Article
MARCH 2024
Development, validation and application of an ion-pair reversed-phase liquid chromatography-tandem mass spectrometry method for the quantification of nusinersen
- Xiao Zhang,
- Chunjie Sha,
- Wei Zhang,
- Fengjuan Zhao,
- Mingli Zhu,
- Guangyi Leng &
- Wanhui Liu
- Pages:305–317
- Published Online:13 MARCH 2024
Perspective
MARCH 2024
Western blotting: evolution of an old analytical method to a new quantitative tool for biomarker measurements
- Pages:319–328
- Published Online:13 MARCH2024