Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis-Reference-Cited by-同舟云学术

Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis

Published:2022-08 Issue:16 Volume:14 Page:1085-1093
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Laurén Anna¹,Braun Manuela²,Cazzin Chiara³,Colleti Kelly⁴,Cox Chris⁵,Dietz Lisa⁶,Emrich Thomas⁷,Geddes Kristin⁸,Herr Kate⁹,Iles Tracy¹⁰,Rogue Alexandra¹¹,Verlinden Yvan¹²,Timmerman Philip¹³

Affiliation:

1. Novo Nordisk A/S, Non-clinical and Clinical Assay Sciences, Global Discovery and Development Sciences, Global Drug Discovery, Maaløv, 2760, Denmark

2. Bayer AG, DMPK Project Management, Research and Development, Pharmaceuticals, Berlin, 13342, Germany

3. Aptuit Srl, an Evotec Company, ADMET & Bioanalytical Sciences Dept., Campus Levi-Montalcini, Verona, 37135, Italy

4. Charles River Laboratories, Laboratory Sciences, Reno, NV 89511, USA

5. PsiOxus Therapeutics, 4–10 The Quadrant, Abingdon, Oxfordshire, OX14 3YS, UK

6. Bayer AG, DMPK Bioanalytics, Research & Development, Pharmaceuticals, Wuppertal, 42096, Germany

7. F. Hoffmann La Roche Pharma Research & Early Development, Pharmaceutical Sciences, Large Molecule Bioanalytical Sciences, Roche Innovation Center Munich, Penzberg, 82377, Germany

8. Merck and Co., Inc., PCD-BA Regulated Immunogenicity, Rahway, NJ, USA

9. Janssen BioTherapeutics, Janssen Research & Development LLC, Spring House, PA 19477, USA

10. Labcorp Drug Development, Biopharmaceutical CMC Solutions, Harrogate, HG3 1PY, UK

11. Department of Biomarker, Charles River Laboratories, Evreux, 27000, France

12. Janssen BioTherapeutics, JBIO Beerse Bioanalysis Laboratory, Beerse, 2340, Belgium

13. European Bioanalysis Forum, Brussels, 1000, Belgium

Abstract

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2022-0170

Reference30 articles.

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