Aim: Stability must be evaluated before quantitation of drugs or metabolites concentrations in biological matrices. We reported a case study where instability of a drug metabolite was mediated by hemolysis. Materials & methods: The instability of both enantiomers of N-desethyloxybutynin was observed in hemolyzed plasma stored at -20°C. The investigations indicated that heme-mediated oxidation converted […]
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 companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity
Aim: Digital ELISA-based assays for blood biomarkers of neurological disease are on the verge of clinical use. Here, we aimed to determine whether different preanalytical blood processing techniques influence results. Materials & methods: Concentrations of neurofilament light chain (NfL), Tau and amyloid beta (Aβ) were measured in human plasma and serum specimens using digital ELISA
Aim: Replicate sample testing has long been regarded as a necessity for bioanalytical laboratory testing, especially in the realm of ligand-binding assays (LBAs). In an era in which results were derived from crude test tube-based assays, the replication of results was warranted. Those assays were often imprecise and required multiple replicates to arrive at results
Aim: Neutralizing anti-drug antibody (NAb) assays are inherently prone to the interference from drug and its soluble target, potentially resulting in erroneous results. An effective approach to improve drug tolerance of an NAb assay is pretreatment of samples with acid to dissociate immune complexes of NAb and drug, followed by separating NAbs from circulating drug
Aim: To develop and validate a simple method using UPLC–MS/MS for determination of apatinib and its three active metabolites in a Phase IV clinical trial. Materials & methods: All compounds were separated on a Hypersil GOLD™ aQ C18 Polar Endcapped LC column (50 × 2.1 mm, 1.9 μm, Thermo) using 5 mmol/l ammonium acetate with
The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers,
Kelly Dong, PhD, Chief Executive Officer, United-Power Pharma Tech Co., Ltd Kelly Dong obtained her PhD degree from McGill University, Canada. Kelly has nearly 25 years of multinational industry experience working for pharmaceutical companies and CROs in Canada, the UK and China. Her scientific expertise encompasses drug metabolism and pharmacokinetics (DMPK) in drug discovery and
The number of gene therapy (GTx) modality therapies in development has grown significantly in the last few years. Adeno-associated virus (AAV)-based delivery approach has become most prevalent among other virus-based GTx vectors. Several regulatory guidelines provide the industry with general considerations related to AAV GTx development including discussion and recommendations related to highly diverse bioanalytical
Aim: Advancements in RNA interference therapeutics have triggered development of improved bioanalytical methods for oligonucleotide metabolite profiling and high-throughput quantification in biological matrices. Results & methodology: HPLC coupled with high-resolution mass spectrometry (LC-HRMS) methods were developed to investigate the metabolism of a REVERSIR™ molecule in vivo. Plasma and tissue samples were extracted using solid-phase extraction