title: Aspects of bioanalytical method validation for the quantitative determination of trace elements.
abstract: Bioanalytical methods are used to quantitatively determine the concentration of drugs, biotransformation products or other specified substances in biological matrices and are often used to provide critical data to pharmacokinetic or bioequivalence studies in support of regulatory submissions. In order to ensure that bioanalytical methods are capable of generating reliable, reproducible data that meet or exceed current regulatory guidance, they are subjected to a rigorous method validation process. At present, regulatory guidance does not necessarily account for nuances specific to trace element determinations. This paper is intended to provide the reader with guidance related to trace element bioanalytical method validation from the authors' perspective for two prevalent and powerful instrumental techniques: inductively coupled plasma-optical emission spectrometry and inductively coupled plasma-MS.
authors.affiliation: RTI International, Research Triangle Park, NC 27709, USA.
authors.forename: Keith E
authors.initials: KE
authors.lastname: Levine
authors.forename: Christopher
authors.initials: C
authors.lastname: Tudan
authors.forename: Peter M
authors.initials: PM
authors.lastname: Grohse
authors.forename: Frank X
authors.initials: FX
authors.lastname: Weber
authors.forename: Michael A
authors.initials: MA
authors.lastname: Levine
authors.forename: Yu-Seon J
authors.initials: YS
authors.lastname: Kim
mesh_terms: D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000592:standards*; D004340:Drug Contamination; D013058:Mass Spectrometry / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D013054:Spectrophotometry, Atomic / Q000592:standards; D014131:Trace Elements / Q000032:analysis* / Q000592:standards; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations; D014131:Trace Elements