Current Regulatory Guidance Pertaining Biomarker Assay Establishment and Industrial Practice of Fit‐for‐Purpose and Tiered Approach
暂无分享,去创建一个
[1] Roger Hayes,et al. Recommendations on biomarker bioanalytical method validation by GCC. , 2012, Bioanalysis.
[2] Sarah Watson,et al. Pragmatic issues in biomarker evaluation for targeted therapies in cancer , 2015, Nature Reviews Clinical Oncology.
[3] H. Soares,et al. Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report , 2005, Pharmaceutical Research.
[4] P. Timmerman. Biomarker assay validation: are we having the right discussions? , 2016, Bioanalysis.
[5] Patrick Bennett,et al. Biomarkers: more of a challenge for bioanalysis than expected. , 2016, Bioanalysis.
[6] Naidong Weng,et al. Overview: Fundamentals of a Bioanalytical Laboratory , 2013 .
[7] Lauren F. Stevenson,et al. The breadth of biomarkers and their assays. , 2016, Bioanalysis.
[8] J Cummings,et al. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs , 2010, British Journal of Cancer.
[9] A. Fourie,et al. Quantitation of leukotriene B(4) in human sputum as a biomarker using UPLC-MS/MS. , 2013, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[10] Vinod P. Shah,et al. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007, The AAPS Journal.
[11] W. Colburn,et al. Biomarkers, Validation and Pharmacokinetic-Pharmacodynamic Modelling , 2003, Clinical pharmacokinetics.
[12] Renuka Pillutla,et al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity). , 2015, Bioanalysis.
[13] Brian Booth,et al. When do you need a validated assay? , 2011, Bioanalysis.
[14] A. P. Valeri,et al. Strategic regulatory approaches for the qualification of a biomarker assay for safety use. , 2013, Bioanalysis.
[15] Hao Wang,et al. Validation and application of an LC-MS/MS method for quantitation of three fatty acid ethanolamides as biomarkers for fatty acid hydrolase inhibition in human plasma. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[16] A. Fourie,et al. A highly sensitive and selective method for the determination of leukotriene B4 (LTB4) in ex vivo stimulated human plasma by ultra fast liquid chromatography-tandem mass spectrometry. , 2013, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.
[17] A. D. Rodrigues,et al. Validation of 4β-hydroxycholesterol and evaluation of other endogenous biomarkers for the assessment of CYP3A activity in healthy subjects. , 2014, British journal of clinical pharmacology.
[18] Viswanath Devanarayan,et al. Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.
[19] Steve Lowes,et al. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers. , 2016, Bioanalysis.
[20] Stephanie Cape,et 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). , 2016, Bioanalysis.
[21] Surinder Kaur,et al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies). , 2015, Bioanalysis.
[22] Richard Houghton,et al. Conference Report: Analytical challenges in the qualification and validation of pharmacodynamic biomarkers. , 2011, Bioanalysis.
[23] Naidong Weng,et al. Relative quantitation of glycoisoforms of intact apolipoprotein C3 in human plasma by liquid chromatography-high-resolution mass spectrometry. , 2013, Analytical chemistry.
[24] Eric Woolf,et al. Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance , 2014, The AAPS Journal.
[25] N. Weng,et al. Tiered Approaches to Chromatographic Bioanalytical Method Performance Evaluation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team , 2014, The AAPS Journal.
[26] Philip Timmerman,et al. Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. , 2014, Bioanalysis.
[27] T. Ward,et al. Fit-for-purpose biomarker method validation in anticancer drug development. , 2010, Drug discovery today.
[28] Naidong Weng,et al. Important considerations for quantitation of small-molecule biomarkers using LC-MS. , 2012, Bioanalysis.
[29] Naidong Weng,et al. Recommendations on the Development of a Bioanalytical Assay for 4β-Hydroxycholesterol, an Emerging Endogenous Biomarker of CYP3A Activity , 2016, The AAPS Journal.
[30] S. Bates,et al. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development. , 2012, Bioanalysis.
[31] William D. Figg,et al. Validation of Analytic Methods for Biomarkers Used in Drug Development , 2008, Clinical Cancer Research.
[32] K. Cowan. Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective. , 2016, Bioanalysis.