Biomarker Assay Validation by Mass Spectrometry.

Szczegóły
Abstrakt

Tytuł:: Biomarker Assay Validation by Mass Spectrometry.
Autorzy:: Fernández-Metzler C; PharmaCadence Analytical Services, LLC, 1440 Industry Road, Hatfield, PA, 19940, USA. .
Ackermann B; Eli Lilly & Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Garofolo F; BRI - a Frontage Company, 8898 Heather St, Vancouver, British Columbia, V6P 3S8, Canada.
Arnold ME; Labcorp Drug Development, 221 Tulip Tree Drive, Westampton, NJ, 08060-5511, USA.
DeSilva B; Bristol-Myers Squibb Co., Route 206 & Province Line Road, Princeton, NJ, 08543, USA.
Gu H; Bristol-Myers Squibb Co., Route 206 & Province Line Road, Princeton, NJ, 08543, USA.
Laterza O; Merck and Co Inc., 90 E Scott Ave, Rahway, NJ, 07065, USA.
Mao Y; Boehringer-Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT, 06877, USA.
Rose M; Gossamer Bio Inc., 3013 Science Park Road, Suite 200, San Diego, CA, 92121, USA.
Vazvaei-Smith F; Merck and Co Inc., 770 Sumneytown Pike, West Point, PA, 19486, USA.
Steenwyk R; Pfizer-Retired, 8739 N Homestead Circle, Irons, MI, 49644, USA.
Źródło:: The AAPS journal [AAPS J] 2022 May 09; Vol. 24 (3), pp. 66. Date of Electronic Publication: 2022 May 09.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Original Publication: Arlington, Va., USA : American Association of Pharmaceutical Scientists, [2004]-
MeSH Terms:: Biological Assay*/methods
Biomarkers/analysis ; Chromatography, Liquid/methods ; Mass Spectrometry/methods ; Reference Standards
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Contributed Indexing:: Keywords: LC-MS/MS; assay validation; biomarkers; context of use; fit-for-purpose; regulated bioanalysis
Substance Nomenclature:: 0 (Biomarkers)
Entry Date(s):: Date Created: 20220509 Date Completed: 20220511 Latest Revision: 20220511
Update Code:: 20240105
DOI:: 10.1208/s12248-022-00707-z
PMID:: 35534647
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Decades of discussion and publication have gone into the guidance from the scientific community and the regulatory agencies on the use and validation of pharmacokinetic and toxicokinetic assays by chromatographic and ligand binding assays for the measurement of drugs and metabolites. These assay validations are well described in the FDA Guidance on Bioanalytical Methods Validation (BMV, 2018). While the BMV included biomarker assay validation, the focus was on understanding the challenges posed in validating biomarker assays and the importance of having reliable biomarker assays when used for regulatory submissions, rather than definition of the appropriate experiments to be performed. Different from PK bioanalysis, analysis of biomarkers can be challenging due to the presence of target analyte(s) in the control matrices used for calibrator and quality control sample preparation, and greater difficulty in procuring appropriate reference standards representative of the endogenous molecule. Several papers have been published offering recommendations for biomarker assay validation. The situational nature of biomarker applications necessitates fit-for-purpose (FFP) assay validation. A unifying theme for FFP analysis is that method validation requirements be consistent with the proposed context of use (COU) for any given biomarker. This communication provides specific recommendations for biomarker assay validation (BAV) by LC-MS, for both small and large molecule biomarkers. The consensus recommendations include creation of a validation plan that contains definition of the COU of the assay, use of the PK assay validation elements that support the COU, and definition of assay validation elements adapted to fit biomarker assays and the acceptance criteria for both.
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