With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a ‘standardized process’ for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies […]
Aim: For the first time, extracts obtained from human plasma samples by electromembrane extraction (EME) were investigated comprehensively with particular respect to phospholipids using ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC–MS/MS). Thhe purpose was to investigate the potential of EME for phospholipid cleanup in different EME systems. Results & discussion: No traces of phospholipids were
Aim: Naloxegol is an oral peripherally acting μ-opioid receptor antagonist approved for the treatment of opioid-induced constipation. Sensitive, robust, bioanalytical methods were required to quantitate naloxegol in human biological matrices as part of the clinical development program. Methodology/results: Analytical plasma samples were prepared using Solid Phase Extraction (SPE) coupled with concentration. The method’s linearity was
Aim: With the advent of rapid metabolic profiling techniques and of portable mass spectrometers we examined whether cells distinguished by their cytology and persistence of human papillomavirus infection, could be easily differentiated by their metabolite profile. Materials & methods: Direct injection electrospray mass spectrometry was used in a nontargeted double-blind experiment. Samples were collected from
Aim: Plasma protein binding (PPB), as a significant influenced factor of pharmacokinetic and pharmacodynamic properties of a medicine, is a suitable index for therapeutic drug monitoring (TDM) strategies. A suitable measurement technique of PPB of patients is in urgent need and attracts many analysts’ attention. Results & methodology: In this study, a novel method was
Background: Incurred sample reanalysis (ISR) is an in-study validation parameter, which reinforces that the validated bioanalytical methods are reproducible. ISR of whole blood samples is complex when the test compounds can interconvert, ex vivo. Fingolimod and fingolimod phosphate are highly distributed in the blood cellular components and undergo rapid interconversion, both in vivo and ex
Aim: High clearance is a commonly encountered issue in drug discovery. Here we present a centralized metabolic soft spot identification assay with adequate capacity and turnaround time to support the metabolic optimization needs of an entire discovery organization. Methodology: An integrated quan/qual approach utilizing both an orthogonal sample-pooling methodology and software-assisted structure elucidation was developed
Aim: A new sensitive LC–MS/MS method for the quantification of atenolol in human plasma and milk has been developed for clinical lactation studies. Methods & results: Atenolol and the internal standard, phenazone, were extracted from biological matrices by protein precipitation. A Phenomenex® C-18 column and gradient chromatographic conditions were used for separation of the analyte,
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at
Aim: Cinitapride (CIN) is a benzamide-derived molecule used for the treatment of gastroesophageal reflux and dyspepsia. Its pharmacokinetics are controversial due to the use of supratherapeutic doses and the lack of sensitive methodology. Therefore, a sensitive and accurate micromethod was developed for its quantitation in human plasma. Results: CIN was extracted from 300 µl of