Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective
Author:
Affiliation:
1. Genentech, Inc., BioAnalytical Sciences, 1 DNA Way, South San Francisco, CA 94080, USA
Publisher
Future Science Ltd
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Link
http://www.future-science.com/doi/pdf/10.4155/bio-2016-0070
Reference16 articles.
1. Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
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3. Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement
4. Validation of Analytic Methods for Biomarkers Used in Drug Development
5. Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis☆
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