title: Technical aspects of inductively coupled plasma bioanalysis techniques.
abstract: This White Paper is focused on the technical aspects regarding quantifying pharmaceutically derived inorganic elements in biomatrices in support of GLP nonclinical and clinical studies using inductively coupled plasma (ICP) techniques. For decades ICP has been used in support of Environmental Protection Agency analyses and has more recently been applied for use in the pharmaceutical industry. Current bioanalytical method validation and sample analysis regulatory guidance applies to chromatographic platforms used for analysis of large- and small-molecule PK and TK assessments; however, it is not directly applicable to all aspects of various ICP techniques. Increasingly, quadrupole and high-resolution ICP-MS methods of analysis are being used to quantify inorganic elements contained in pharmaceutical compounds and biomatrices. Many elements occur endogenously in biomatrices, affecting quantification of blanks, standard curve samples, QC samples, and the selection of appropriate levels for the LLOQ.
authors.affiliation: MPI Research, 54943 N. Main Street, Mattawan, MI 49071, USA. jennifer.ammerman@ mpiresearch.com
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ammerman
authors.forename: Chaoyang
authors.initials: C
authors.lastname: Huang
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Sailstad
authors.forename: Jaap
authors.initials: J
authors.lastname: Wieling
authors.forename: Monica Lee
authors.initials: ML
authors.lastname: Whitmire
authors.forename: Daniel
authors.initials: D
authors.lastname: Wright
authors.forename: Patricia
authors.initials: P
authors.lastname: de Lisio
authors.forename: Fergus
authors.initials: F
authors.lastname: Keenan
authors.forename: Ed
authors.initials: E
authors.lastname: McCurdy
authors.forename: Bert
authors.initials: B
authors.lastname: Woods
authors.forename: Phillip
authors.initials: P
authors.lastname: Wang
authors.forename: Anastasia
authors.initials: A
authors.lastname: Osredkar
authors.forename: Jessica
authors.initials: J
authors.lastname: Ciaravino
mesh_terms: D015415:Biomarkers / Q000032:analysis / Q000097:blood / Q000134:cerebrospinal fluid / Q000652:urine; D002138:Calibration; D055808:Drug Discovery / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D004602:Elements; D017408:Guidelines as Topic; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000097:blood / Q000134:cerebrospinal fluid / Q000652:urine; D011786:Quality Control; D012015:Reference Standards; D013048:Specimen Handling; D013054:Spectrophotometry, Atomic / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers; D004602:Elements; D004364:Pharmaceutical Preparations