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Page 1
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bower J, Zimmer J, McCown S, Tabler E, Karnik S, Kar S, Sales K, Vance J, Barry C, Keyhani A, Williams D, Lester T, Garofolo F, Satterwhite C, Groeber E, Renfrew H, Lin J, Cape S, O'Dell M, Fang X, Brant A, Garofolo W, Savoie N, Hayes R, Simchik S, Sun R, Bravo O, Dufield D, Luna M, Xu A, Kane C, Farley E, Sanghvi M, Hays A, Lowes S, Islam R, Hoffpauir B, Beaver C, Dong K, Desai-Krieger D. Bower J, et al. Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13. Bioanalysis. 2021. PMID: 33847160 Free article.
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: bower 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: bower j. Bioanalysis. 2014 Oct;6(20):2713-20. doi: 10.4155/bio.14.231. Bioanalysis. 2014. PMID: 25413703 Free article. No abstract available.
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, Hayes R, Lowes S, Nicholson R, LeLacheur R, Bravo J, Shoup R, Dumont I, Carbone M, Zimmer J, Ortuno J, Caturla MC, Datin J, Lansing T, Fatmi S, Struwe P, Sheldon C, Islam R, Yu M, Hulse J, Kamerud J, Lin J, Doughty J, Kurylak K, Tang D, Buonarati M, Blanchette A, Levesque A, Gagnon-Carignan S, Lin J, Ray G, Liu Y, Khan M, Xu A, El-Sulayman G, DiMarco C, Bouhajib M, Tacey D, Jenkins R, der Strate Bv, Briscoe C, Karnik S, Rhyne P, Garofolo W, Schultz G, Roberts A, Redrup M, DuBey I, Conliffe P, Pekol T, Hantash J, Cojocaru L, Allen M, Reuschel S, Watson A, Farrell C, Groeber E, Malone M, Nowatzke W, Fang X. Bower J, et al. Bioanalysis. 2014;6(22):2957-63. doi: 10.4155/bio.14.287. Bioanalysis. 2014. PMID: 25496252 Free article.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. Gupta S, et al. Among authors: bower j. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064 Free article.
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Islam R, Briscoe C, Bower J, Cape S, Arnold M, Hayes R, Warren M, Karnik S, Stouffer B, Xiao YQ, van der Strate B, Sikkema D, Fang X, Tudoroniu A, Tayyem R, Brant A, Spriggs F, Barry C, Khan M, Keyhani A, Zimmer J, Caturla MC, Couerbe P, Khadang A, Bourdage J, Datin J, Zemo J, Hughes N, Fatmi S, Sheldon C, Fountain S, Satterwhite C, Colletti K, Vija J, Yu M, Stamatopoulos J, Lin J, Wilfahrt J, Dinan A, Ohorodnik S, Hulse J, Patel V, Garofolo W, Savoie N, Brown M, Papac D, Buonarati M, Hristopoulos G, Beaver C, Boudreau N, Williard C, Liu Y, Ray G, Warrino D, Xu A, Green R, Hayward-Sewell J, Marcelletti J, Sanchez C, Kennedy M, Charles JS, Bouhajib M, Nehls C, Tabler E, Tu J, Joyce P, Iordachescu A, DuBey I, Lindsay J, Yamashita J, Wells E. Islam R, et al. Among authors: bower j. Bioanalysis. 2018 Apr 1;10(7):433-444. doi: 10.4155/bio-2018-0014. Epub 2018 Apr 27. Bioanalysis. 2018. PMID: 29701066 Free article.
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Nehls C, Buonarati M, Cape S, Islam R, Satterwhite C, Briscoe C, Hayes R, Dinan A, Sales K, Anderson S, Vance J, Lindsay J, Zimmer J, Couerbe P, Khadang A, Maasjo S, Bravo O, Lindley K, Moran L, Sangster T, Vija J, Stamatopoulos J, Lin J, Reuschel S, Underberg A, MacNeill R, Matassa L, Spytko A, Garofolo W, Savoie N, Rhyne P, Ambrosius J, Barra V, Dufield D, Luna M, Spriggs F, Fedorov E, Ritzén H, Fatmi S, Kane C, Bouhajib M, DiMarco C, Iordachescu A, Tudoroniu A, Farley E, Stouffer B, Tabler E, McCown S, Bower J, Harrison T, Karnik S, Brown M, Joyce P, DuBey I, Hoffpauir B, Boudreau N, Bergeron J, Wang H, Feng H, Zhou S, Wells E, Pirro J, Fang X, Shi J, Yang C. Nehls C, et al. Among authors: bower j. Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30. Bioanalysis. 2019. PMID: 31565956 Free article.
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. Hersey S, et al. Among authors: bower j. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974 Free article.
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. Szapacs M, et al. Among authors: bower j. Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31. Bioanalysis. 2023. PMID: 37650500 Free article.
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