References
- Zimmer R . Evaluation and regulation of biomarkers. A public health perspective. PHG Foundation. Presented at : OECD Workshop on Policy Issues for the Development and Use of Biomarkers in Health. Hinxton, UK, 6 October 2008.
- Stevenson LF . Biomarkers, PK and immunogenicity: are we ready for integration?Bioanalysis8 (22), 2287–2289 (2016).
- King R , Fernandez-MetzlerC, BachmannL. Biomarkers and the sample matrix: challenges and opportunities. Bioanalysis8 (22), 2291–2293 (2016).
- Bennett P . Biomarkers: more of a challenge for bioanalysis than expected. Bioanalysis8 (22), 2295–2298 (2016).
- Chappell DL , LeeAYH, BernsteinHS, LassmanME, LaterzaOF. Development and validation of an IA-LC/MS method to quantitate active and total BNP in human plasma. Bioanalysis8 (22), 2341–2349 (2016).
- Ackermann BL . Immunoaffinity MS: adding increased value through hybrid methods. Bioanalysis8 (15), 1535–1537 (2016).
- Schofield C , FischerSK, TownsendMJet al. Characterization of IL-17AA and IL-17FF in rheumatoid arthritis and multiple sclerosis. Bioanalysis8 (22), 2317–2327 (2016).
- Fischer SK , Carrasco-TrigueroM, HongKet al. Commercial biomarker assays: friend and foe. Bioanalysis8 (22), 2351–2362 (2016).
- Qi Z , WangL, HeA, Ma-EdmondsM, CogswellJ. Evaluation and selection of a non-PCR based technology for improved gene expression profiling from clinical formalin-fixed, paraffin-embedded samples. Bioanalysis8 (22), 2305–2316 (2016).
- Cowan K , GaoX, ParabVet al. Fit-for-purpose biomarker immunoassay qualification and validation: three case studies. Bioanalysis8 (22), 2329–2340 (2016).
- US FDA, US Department of Health and Human Services . Draft Guidance for Industry: Bioanalytical Method Validation (Revised). September 2013. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf
- Arnold ME , BoothB, KingL, RayC. Workshop report: Crystal City VI – bioanalytical method validation for biomarkers. AAPS J. doi: 10.1208/s12248-016-9946-6 (2016) ( Epub ahead of print).
- Timmerman P . Biomarker assay validation: are we having the right discussions?Bioanalysis8 (22), 2299–2303 (2016).
- Yang E , WelinkJ, CapeSet al. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS). Bioanalysis8 (22), 2363–2378 (2016).