Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis / Anna Laurén, Manuela Braun, Chiara Cazzin, Kelly Colleti, Chris Cox, Lisa Dietz, Thomas Emrich, Kristin Geddes, Kate Herr, Tracy Iles, Alexandra Rogue, Yvan Verlinden, Philip Timmerman

In this manuscript, the European Bioanalysis Forum reports back on their discussions on practical and scientific considerations related to bioanalytical applications of quantitative polymerase chain reaction. This publication follows an earlier publication in which the European Bioanalysis Forum recommends to consider principles of context of use when defining assay acceptance criteria for method validation criteria and sample analysis.

Medienart:

E-Artikel

Erscheinungsjahr:

2022

Erschienen:

Erscheinungsort nicht ermittelbar: 2022

Enthalten in:

Bioanalysis

Sprache:

Englisch

Beteiligte Personen:

Laurén, Anna [VerfasserIn]
Braun, Manuela [VerfasserIn]
Cazzin, Chiara [VerfasserIn]
Colleti, Kelly [VerfasserIn]
Cox, Chris [VerfasserIn]
Dietz, Lisa [VerfasserIn]
Emrich, Thomas [VerfasserIn]
Geddes, Kristin [VerfasserIn]
Herr, Kate [VerfasserIn]
Iles, Tracy [VerfasserIn]
Rogue, Alexandra [VerfasserIn]
Verlinden, Yvan [VerfasserIn]
Timmerman, Philip [VerfasserIn]

Links:

FID Access [lizenzpflichtig]

Themen:

Assay development
Assay validation
Biomarker
Context of use
Quantitative polymerase chain reaction
Regulated bioanalysis

Umfang:

1 Online-Ressource (9 p)

doi:

10.4155/bio-2022-0170

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

KFL011092890