Aim: Volumetric absorptive microsampling (VAM) is being increasingly applied in nonclinical pharmacokinetic studies. Although there are published results for VAM use in small molecule pharmacokinetics (PK) studies, there is limited data on the utility of VAM for protein therapeutics. Results: We describe the use of Mitra® microsampler for blood sampling, ELISA quantitation and PK analysis […]
The European Bioanalysis Forum is providing a proposal on experiments to be conducted if processed samples are to be stored for a period of time, either after an initial injection or if processed samples are to be stored for a period of time prior to their first injection. Using survey information and extensive discussion an
Welcome to the 11th volume of Bioanalysis and we want to take this opportunity to wish you all a Happy New Year. We would like to take this opportunity to reflect on the past 12 months from the perspective of the journal. We want to thank all our authors, readers and reviewers, as well as
Aim: The objective of this study was to evaluate the rapid equilibrium dialysis (RED) device in protein binding assays in diluted protein matrices and to improve the accuracy of the unbound fraction (fu) measurement. Methodology: Protein binding assays of drug compounds in bovine serum albumin solutions and human plasma with different folds of dilution were
Aim: Numerous guideline studies required for regulatory toxicity testing now include the measurement of the thyroid hormones 3,3′,5-triiodo-L-thyronine (T3) and L-thyroxine (T4) in blood serum from rodents. A rapid, high-throughput method for the determination of the thyroid hormones T4 and T3 is reported. Materials & methods: Sample preparation is done using a 96-well microtiter plate
Aim: GW788388 is a selective and orally active TGF-β1 receptor inhibitor that shows potent activity in renal fibrosis. We aimed to establish and validate a simple and sensitive ultra-performance LC–MS/MS method for the determination of GW788388 in plasma samples. Methodology & results: GW788388 in rat plasma was processed with protein precipitation method and then separated
Background: PEGylation technology is one of long-acting delivery (LAD) platforms used to increase half-life of protein therapeutics. However, PEGylation of anti-Factor D Fab (PEG-aFD) poses challenges for detecting anti-drug antibody (ADA) to both Fab and polyethylene glycol (PEG) portions. Results: Although the bridging ELISA using traditional assay diluent containing Tween 20 is good for detecting
One of the problems associated with the consumption of new psychoactive substances is that in most scenarios of acute toxicity the possibility of quick clinical action may be impaired because many screening methods are not responsive to them, and laboratories are not able to keep pace with the appearance of new substances. For these reasons,
Background: This paper describes for the first-time analytical procedures established to resolve the challenges associated with simultaneous and direct quantification of ataluren and ataluren-O-1β-acyl glucuronide (AAG) by LC–MS/MS in human plasma and urine matrices. Methodology/results: The plasma quantification method was validated for calibration range of 12.5–12500 ng/ml for ataluren and 6.25–2500 ng/ml for AAG. The