Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies
- 1 July 2011
- journal article
- Published by Elsevier in Journal of Pharmaceutical and Biomedical Analysis
- Vol. 55 (5) , 869-877
Abstract
No abstract availableKeywords
This publication has 22 references indexed in Scilit:
- Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugsBritish Journal of Cancer, 2010
- Immunoassay for human serum hemojuvelinHaematologica, 2010
- Comparison of Multiplex Immunoassay PlatformsClinical Chemistry, 2010
- Antibody-Based Protein Multiplex Platforms: Technical and Operational ChallengesClinical Chemistry, 2010
- “Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical StudiesThe AAPS Journal, 2009
- Validation of Analytic Methods for Biomarkers Used in Drug DevelopmentClinical Cancer Research, 2008
- Key elements of bioanalytical method validation for macromoleculesThe AAPS Journal, 2007
- Key elements of bioanalytical method validation for small moleculesThe AAPS Journal, 2007
- Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serumJournal of Pharmaceutical and Biomedical Analysis, 2005
- Biomarkers and surrogate endpoints: Preferred definitions and conceptual frameworkClinical Pharmacology & Therapeutics, 2001