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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY. Piccoli S, et al. Among authors: allinson j. Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10. Bioanalysis. 2019. PMID: 31820675 Free article.
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 MC, 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, Lin ZJ, 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, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, Fang X. Lowes S, et al. Among authors: allinson j. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394 Free article.
Recommendations on biomarker bioanalytical method validation by GCC.
Hougton R, Gouty D, Allinson J, Green R, Losauro M, Lowes S, LeLacheur R, Garofolo F, Couerbe P, Bronner S, Struwe P, Schiebl C, Sangster T, Pattison C, Islam R, Garofolo W, Pawula M, Buonarati M, Hayes R, Cameron M, Nicholson R, Harman J, Wieling J, De Boer T, Reuschel S, Cojocaru L, Harter T, Malone M, Nowatzke W. Hougton R, et al. Among authors: allinson j. Bioanalysis. 2012 Oct;4(20):2439-46. doi: 10.4155/bio.12.197. Bioanalysis. 2012. PMID: 23157353 Free article.
Ask the experts: automation: part I.
Allinson JL, Blick KE, Cohen L, Higton D, Li M. Allinson JL, et al. Bioanalysis. 2013 Aug;5(16):1953-62. doi: 10.4155/bio.13.181. Bioanalysis. 2013. PMID: 23937129
Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, LeLacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Zimmer J, Caturla MC, Couerbe P, Awaiye K, Fatmi S, Farmen R, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Zhang T, Pasas-Farmer S, Garofolo W, Moussallie M, Rocci M, Allinson J, Gouty D, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Hayes R, Bouhajib M, Stipancic M, Nicholson R, Nehls C, Warren M, Karnik S, Houghton R, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Lowes S, et al. Among authors: allinson j. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155. Bioanalysis. 2014. PMID: 25384591 Free article.
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Rocci M, Lowes S, Shoup R, Garofolo F, Farmen R, Zhang T, Allinson J, Gouty D, Hayes R, Nicholson R, Houghton R, Dumont I, LeLacheur R, Zimmer J, Cruz Caturla M, Couerbe P, Awaiye K, Fatmi S, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Pasas-Farmer S, Garofolo W, Moussallie M, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Bouhajib M, Stipancic M, Nehls C, Warren M, Karnik S, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Rocci M, et al. Among authors: allinson j. Bioanalysis. 2014 Oct;6(20):2713-20. doi: 10.4155/bio.14.231. Bioanalysis. 2014. PMID: 25413703 Free article. No abstract available.
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. Amaravadi L, et al. Among authors: allinson j. Bioanalysis. 2015 Dec;7(24):3107-24. doi: 10.4155/bio.15.226. Epub 2015 Dec 4. Bioanalysis. 2015. PMID: 26635247 Free article.
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. Richards S, et al. Among authors: allinson j. Bioanalysis. 2016 Dec;8(23):2475-2496. doi: 10.4155/bio-2016-4989. Bioanalysis. 2016. PMID: 27855512 Free article.
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
Cape S, Islam R, Nehls C, Allinson J, Safavi A, Bennett P, Hulse J, Beaver C, Khan M, Karnik S, Caturla MC, Lowes S, Iordachescu A, Silvestro L, Tayyem R, Shoup R, Mowery S, Keyhani A, Wakefield A, Li Y, Zimmer J, Torres J, Couerbe P, Khadang A, Bourdage J, Hughes N, Awaiye K, Matthews B, Fatmi S, Johnson R, Satterwhite C, Yu M, Lin J, Cojocaru L, Fiscella M, Thomas E, Kurylak K, Kamerud J, Lin ZJ, Garofolo W, Savoie N, Buonarati M, Boudreau N, Williard C, Liu Y, Warrino D, Kale P, Adcock N, Shekar R, O'Connor E, Ritzen H, Sanchez C, Hayes R, Bouhajib M, Savu SR, Stouffer B, Tabler E, Tu J, Briscoe C, der Strate BV, Rhyne P, Conliffe P, DuBey I, Yamashita J, Tang D, Groeber E, Vija J, Malone M, Osman M. Cape S, et al. Among authors: allinson j. Bioanalysis. 2017 Apr;9(7):505-516. doi: 10.4155/bio-2017-5000. Epub 2017 Mar 24. Bioanalysis. 2017. PMID: 28339299 Free article.
57 results