8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bower J, Fast D, Garofolo F, Gouty D, et al. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287.
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7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Rocci M, Gouty D, et al. Bioanalysis. 2014 Oct; 6(20):2713-20. doi: 10.4155/bio.14.231.
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2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS.
Stevenson L, Wright L, Losauro M, Gouty D, et al. Bioanalysis. 2013 Dec;5(23):2903-18. doi: 10.4155/bio.13.238. Epub 2013 Oct 10.
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Recommendations on biomarker bioanalytical method validation by GCC.
Hougton R, Gouty D, Losauro M, et al. Bioanalysis. 2012 Oct; 4(20):2439-46. doi: 10.4155/bio.12.197.
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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
Nicholson R, Safavi A, Gouty D, et al Bioanalysis. 2012 Oct; 4(19):2335-42. doi: 10.4155/bio.12.213.
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes S, Safavi A, Gouty D, Wright L, et al Bioanalysis. 2012 Sep; 4(17):2117-26.
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Inhibition of oncogenic Pim-3 kinase modulates transformed growth and chemosensitizes pancreatic cancer cells to gemcitabine
Xu, D., Cobb, Witherspoon, S. M., Baines, A. T. (2013). Cancer Biology and Therapy, 14(6), 492–501. doi:10.4161/cbt.24343
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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part3—LBA, Biomarkers and Immunogenicity)
Amaravadi, L., Song, A., Myler, H., Thway, T., Kirshner, S., Devanarayan, V., G Ni, Y., Garofolo, F., Birnboeck, H., Richards, S., Gupta, S., Luo, L., Kingsley, C., Salazar-Fontana, L., Fraser, S., Gorovits, B., Allinson, J., Barger, T., Chilewski, S., Scheel Fjording, M., Haidar, S., Islam, R., Jaitner, B., Kamerud, J., Katori, N., Krinos-Fiorotti, C., Lanham, D., Ma, M., McNally, J., Morimoto, A., Mytych, D., Nogueira da Costa, A., Papadimitriou, A., Pillutla, R., Ray, S., Safavi, A., Savoie, N., Schaefer, M., Shih, J., Smeraglia, J., Skelly, M. F., Spond, J., Staack, R.F., Stouffer, B., Tampal, N., Torri, A., Welink, J., Yang, T., Zoghbi, J. Bioanalysis 2015 Dec 4; 7 (24):3107-24. Epub 2015 Dec 4.
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes, S., Boterman, M., Doig, M., Breda, M., Jersey, J., Lelacheur, R., Shoup, R., Garofolo, F., Dumont, I., Martinez, S., Needham,S., Zimmer, J., Caturla, M.C., Couerbe, P., Maltas, J., Steffen, R., Petrilla, J., Safavi, A., Awaiye, K., Bhatti, M., Sheldon, C., Schiebl, C., Struwe, P., Turk, D., Sangster, T., Pattison, C., Fast, D., Goodwin, L., Kamerud, J., Dinan, A., Mamelak, D., Islam, R., Segers, R., John Lin, Z., Hillier, J., Garofolo, W., Folguera, L., Zimmer, D., Zimmermann, T., Pawula, M., Moussallie, M., de Souza Teixeira, L., Rocha, T., Allinson, J., Jardieu, P., Tang, D., Gouty, D., Wright, L., Truog, J., Lin, J., Yamashita, Y., Khan, M., Liu, Y., Xu, A., Lundberg, R., Cox, C., Breau, A., Hayes, R., Bigogno, C., Schoutsen, D., Dilger, C., Jonker, J., Bouhajib, M., Levesque, A., Gagnon-Carignan, S., Harman, J. Nicholson, R., Jenkins, R., Warren, M., Hung Lin, M., Karnik, S., De Boer, T., Houghton, R., Green, R., Demaio, W., Sable, R., Smith, K., Siethoff, C., Cojocaru, L., Allen, M., Reuschel, S., Pilar Gonzalez, P., Harter, T., Fatmi, S., Rock, M., Vija, J., Sayyarpour, F., Malone, M., Nowatzke, W., Best, S., Fang, X. Bioanalysis 2012 Sep;4 (17):2117-26
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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity).
Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R. Bioanalysis. 2016 Dec;8(23):2475-2496.
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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3–LBA, biomarkers and immunogenicity).
Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, Allinson J, Barger T, Chilewski S, Fjording MS, Haidar S, Islam R, Jaitner B, Kamerud J, Katori N, Krinos-Fiorotti C, Lanham D, Ma M, McNally J, Morimoto A, Mytych D, Nogueira da Costa A, Papadimitriou A, Pillutla R, Ray S, Safavi A, Savoie N, Schaefer M, Shih J, Smeraglia J, Skelly MF, Spond J, Staack RF, Stouffer B, Tampal N, Torri A, Welink J, Yang TY, Zoghbi J. Bioanalysis. 2015 Dec;7(24):3107-24.
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