title: Stabilization of clinical samples collected for quantitative bioanalysis--a reflection from the European Bioanalysis Forum.
abstract: In bioanalysis of small molecules, the analyte concentration in the measured samples should reflect the concentration during sample collection. Precautions may be needed to prevent over- or under-estimation of the obtained result. This might require the addition of stabilizers to prevent degradation or nonspecific binding. For unstable drugs, it is essential to know how analytes can be stabilized before the start of the clinical study. Although the stabilization methods are well documented, the impact of the stabilization on the clinical workflow is not properly addressed. Already during method development, the clinical implications in terms of personnel safety, ease of use, training possibilities and staff capacity should be taken into account, and validation of the bioanalytical method should reflect collection procedures.
authors.affiliation: Bioanalytical Laboratory, PRA Health Sciences, Westerbrink 3, 9405 BJ Assen, The Netherlands.
authors.forename: Martijn
authors.initials: M
authors.lastname: Hilhorst
authors.forename: Peter
authors.initials: P
authors.lastname: van Amsterdam
authors.forename: Katja
authors.initials: K
authors.lastname: Heinig
authors.forename: Elke
authors.initials: E
authors.lastname: Zwanziger
authors.forename: Richard
authors.initials: R
authors.lastname: Abbott
mesh_terms: D000327:Adsorption; D000975:Antioxidants / Q000494:pharmacology; D001774:Blood Chemical Analysis; D005060:Europe; D006801:Humans; D006863:Hydrogen-Ion Concentration; D006868:Hydrolysis; D008027:Light; D013048:Specimen Handling / Q000379:methods*; D013696:Temperature; D016482:Urinalysis
chemical_list: D000975:Antioxidants