Decentralized clinical trial design using blood microsampling technology for serum bioanalysis.

Alternatives to phlebotomy in clinical trials increase options for patients and clinicians by simplifying and increasing accessibility to clinical trials. The authors investigated the technical and logistical considerations of one technology compared with phlebotomy. Paired samples were collected from 16 donors via a second-generation serum gel microsampling device and conventional phlebotomy.

Data driven CRO benchmarking for biomarker analysis.

Outsourcing is a common strategy across the pharmaceutical industry and clinical research. CROs offer many choices for selecting outsourcing partners for bioanalytical and biomarker support. We aimed this paper to provide critical insights into CRO benchmarking and selection using a bioanalytical challenge approach performing fit-for-purpose ligand-binding assay.

Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis.

Evaluation of a novel microsampling device for its use in clinical sample collection and biomarker analysis. Matching samples were collected from 16 healthy donors (ten females, six males; age 42 ± 20) via K2EDTA touch activated phlebotomy (TAP) device and phlebotomy. The protein profile differences between sampling groups was evaluated using aptamer-based proteomic assay SomaScan and selected ELISA.

Signal suppression/enhancement in HPLC-ESI-MS/MS from concomitant medications.

This paper presents a study of the signal suppression and enhancement effects in assays based on HPLC-ESI-MS/MS detection. The major focus was to investigate the effect of signal suppression/enhancement of typical co-administered (concomitant) medications, i.e.

Method for internal standard introduction for quantitative analysis using on-line solid-phase extraction LC-MS/MS.

A novel approach for on-line introduction of internal standard (IS) for quantitative analysis using LC-MS/MS has been developed. In this approach, analyte and IS are introduced into the sample injection loop in different steps. Analyte is introduced into the injection loop using a conventional autosampler (injector) needle pickup from a sample vial.

Development and application of a new on-line SPE system combined with LC-MS/MS detection for high throughput direct analysis of pharmaceutical compounds in plasma.

A technique using a fully automated on-line solid phase extraction (SPE) system (Symbiosis, Spark Holland) combined with liquid chromatography (LC)-mass spectrometry (MS/MS) has been investigated for fast bioanalytical method development, method validation and sample analysis using both conventional C18 and monolithic columns. Online SPE LC-MS/MS methods were developed in the automated mode for the quantification of model compounds (propranolol and diclofenac) directly in rat plasma. Accuracy and precision using online SPE LC-MS/MS with conventional C18 and monolithic columns were in the range of 88-111% and 0.

Increase of the LC-MS/MS sensitivity and detection limits using on-line sample preparation with large volume plasma injection.

Large volume injection (LVI) has systematically been studied to improve LC-MS/MS sensitivity (signal-to-noise ratio, or S/N) and detection limits. The method of LVI was combined with on-line solid phase extraction (on-line SPE) and LC-MS/MS detection for analysis of compounds directly in plasma. It was demonstrated that LVI of plasma with on-line SPE-LC-MS/MS allows for improvement of sensitivity and detection limits without compromising chromatographic peak shape and resolution and inducing significant matrix and signal suppression effects.

Small molecule analysis by MALDI mass spectrometry.

This review focuses on the application of matrix assisted laser desorption/ionization (MALDI) mass spectrometry to the characterization of molecules in the low mass range (<1500 Da). Despite its reputation to the contrary, MALDI is a powerful technique to provide both qualitative and quantitative determination of low molecular weight compounds. Several approaches to minimize interference via sample preparation and matrix selection are discussed, as well as coupling of MALDI to liquid and planar chromatographic techniques to extend its range of applicability.