INTER-LABORATORY REPRODUCIBILITY OF BIOANALYTICAL UHPLC-MS/MS METHOD

The reproducibility of phospholipid analyses by MALDI-MSMS.

The identification of phosphocholine and phosphoethanolamine lipids by MALDI TOF/TOF, including characterisation of the headgroup and delineation of the acyl chain at each position of the glycerol backbone, has been explored using lipids representative of each type. The relative intensities of fragments involving the neutral loss of one or other of the acyl chains from ion adducts of 1-palmitoy...

Bioanalytical method validation

A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...

Good preclinical bioanalytical chemistry requires proper sampling from laboratory animals: automation of blood and microdialysis sampling improves the productivity of LC/MSMS.

The preclinical bioanalytical process with animal models begins with sampling biological fluids and tissue. The goal is to understand oral absorption kinetics, distribution, metabolism, excretion, blood brain barrier penetration, drug-drug interactions, and the influences on biomarkers, hematology, electrophysiology, cardiology, blood pressure and behavior. An overview is obtained by periodic b...

Multi-laboratory inter-institute reproducibility study of IVOCT and IVUS assessments using published consensus document definitions.

AIMS The aim of this study was to investigate the reproducibility of intravascular optical coherence tomography (IVOCT) assessments, including a comparison to intravascular ultrasound (IVUS). Intra-observer and inter-observer variabilities of IVOCT have been previously described, whereas inter-institute reliability in multiple laboratories has never been systematically studied. METHODS AND RE...

Bioanalytical Method Development Strategy for Therapeutic Peptides