In this interview, John Kadavil (US FDA; MA, USA) shares his thoughts on the draft ICH M10 guidance for bioanalytical method validation, indicating how this will change the bioanalytical regulatory landscape.
In this interview, Eric Woolf (Merck; PA, USA) provides an overview of the draft ICH M10 guidance for bioanalytical method validation, indicating why there is a need for new guidance despite many BMV guidance currently being available.
In this interview, Wenying Jian (Janssen Research & Development, Johnson & Johnson; NY, USA) describes the basic principles of hybrid LBA/LC–MS and how this technique can be used to quantify proteins.
Hear more about the recent mass spectrometry product launches from SCIEX announced at ASMS 2019, including the new Acoustic Ejection Mass Spectrometry technology, in this interview with Neil Walsh (SCIEX; MA, USA).
In this interview, Zamas Lam (QPS; DE, USA) discusses various methods that can be used to quantify oligonucleotide drugs and the progress that has been made to regulate and standardize oligonucleotide analysis in recent years.
In this interview, Stephanie Traub (Cancer Research UK; London, UK) discusses her work as a biomarker specialist and the challenges she faces when developing biomarker strategies.
In this interview, Annick De Vries (Sanquin; Amsterdam, Netherlands) discusses how personalized sampling can be utilised to achieve optimal PK/PD data, and how PK measurements translate into real life.
In this interview, David Harris (Charles River Laboratories; NC, USA) discusses the current global landscape for cell therapy, associated safety concerns and challenges, and preclinical animal models that are used to evaluate cellular therapies.
Discover more about the development of CAR-T cell therapies, their bioanalytical challenges and specialized antibody reagents that can be ustilized to overcome these in this interview with Michael Schwenkert (Bio-Rad Laboratories; Germany).
Find out more about the role of exosomes in flow cytometry studies and future pharmacological developments in this interview with Joyce Slusser (KCAS; KS, USA).