Genomic Biomarkers for Pharmaceutical Development: Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration
- ISBN-10
- 0128063564
- ISBN-13
- 9780128063569
- Series
- Genomic Biomarkers for Pharmaceutical Development
- Category
- Medical
- Pages
- 208
- Language
- English
- Published
- 2013-07-16
- Publisher
- Elsevier Inc. Chapters
- Authors
- Philip Brohawn, Bahija Jallal, Brandon W. Higgs
Description
This chapter presents the processes required for the translation of a biomarker discovery from the research laboratory into a validated diagnostic for clinical application. To fully investigate the topic of assay validation, a brief review of the current regulatory guidance will be discussed, and thereafter this is used as the framework for topics surrounding assay validation. The time-sensitive stages in the assay development process and agreement with clinical development timelines are critical to delivering a viable clinic-ready assay. Methods to best maneuver this are presented to help emphasize the necessary level of validation for use of an assay in a clinical setting. Each pertinent stage is then described, and key focus areas are highlighted. For certain stages of the development process, such as cut-point determination, multiple vs. single analyte, classifier training/testing, and precision determination, various statistical arguments are presented to illustrate common misconceptions or potential pitfalls.
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Other editions
-
- 2013-07-16
- 208 pages
- Ebook
- Elsevier Inc. Chapters
-
- 2013-07-16
- 208 pages
- Ebook
- Elsevier Inc. Chapters
-
- 2013-07-16
- 208 pages
- Ebook
- Elsevier Inc. Chapters
-
- 2013-07-16
- 208 pages
- Ebook
- Elsevier Inc. Chapters
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