In this interview we caught up with Hua Li (Boehringer Ingelheim Pharmaceuticals, CT, USA) to discuss her research and the inspiration for her 2018 Bioanalysis publication concerning the use of Mitra® microsampling for PK bioanalysis of monoclonal antibodies.
A collaborative team of researchers based at the Wyss Institute (Harvard University, MA, USA) has developed linked organ-on-a-chip systems that could be used to quantitatively predict drug pharmacokinetics, addressing some of the limitations of preclinical studies.
Receptor occupancy measurement by flow cytometry is a rapid, quantifiable and an important addition to PK and PD data in the biopharmaceutical development process.
In this commentary, the author aims to provide some clarity on accuracy-related expectations for the regulated bioanalysis of ‘endogenous’ analytes.
Imperacer (Immuno-PCR) method for ultra sensitive quantification of Interleukin-6 to support clinical Phase III trial (Chimera Biotec)
Exponential signal amplification on the Imperacer platform allows reduction of sample volume to a few microliter, still maintaining single digit pg/ml sensitivity for study support wherever sample volume is critical.
Development of an Excel-based laboratory information management system for improving workflow efficiencies in early ADME screening
In this methodology Xinyan Lu (GlaxoSmithKline R&D, China) details the development of an Excel-based laboratory information management system for improving workflow efficiencies in early ADME screening.
Proposal for a harmonized descriptive analyte nomenclature for quantitative large-molecule bioanalysis
In this Opinion article the authors aim to provide a nomenclature for large-molecule analytes, to avoid confusion and inconsistencies in quantitative bioanalsysis.
In this special report the authors discuss possible methodological and technological future advancements for the employment of MS imaging in pharmaceutical research and development.
European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development
This report discusses EBF recommendations on the bioanalysis of biomarkers in drug development.
Integration of bioanalytical measurements using PK–PD modeling and simulation: implications for antibody–drug conjugate development
In this review the authors discuss the application of PK/PD modeling and simulation for quantitative integration of diverse bioanalytical data available from different stages of ADC development.