Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development.

Autor: Thway, T. M., Wang, Y. M., Booth, B. P., Maxfield, K., Huang, S. M., Zineh, I.

Publikováno v: AAPS Journal; Jan2020, Vol. 22 Issue 1, p1-6, 6p

P159 - Totality of evidence for ABP 980, a trastuzumab biosimilar: results of chemo-synergy studies in combination with pertuzumab

Autor: Kolberg, H.-C., Thway, T., Hanes, V.

Publikováno v: In The Breast April 2021 56 Supplement 1:S83-S83

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).

Autor: Booth B; US FDA, Silver Spring, MD, USA., Stevenson L; Biogen, Cambridge, MA, USA., Pillutla R; Bristol-Myers Squibb, Princeton, NJ, USA., Buonarati M; Intertek, San Diego, CA, USA., Beaver C; Syneos Health, Princeton, NJ, USA., Fraier D; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Garofolo F; Angelini Pharma, Rome, Italy., Haidar S; US FDA, Silver Spring, MD, USA., Islam R; Celerion, Lincoln, NE, USA., James C; Amgen Research, Thousand Oaks, CA, USA., Kadavil J; US FDA, Silver Spring, MD, USA., Kavetska O; Pfizer, Groton, CT, USA., Li F; PPD, Middleton, WI, USA., Satterwhite C; Charles River, Reno, NV, USA., Savoie N; CFABS, Montreal, QC, Canada., Subramaniam S; US FDA, Silver Spring, MD, USA., Tampal N; US FDA, Silver Spring, MD, USA., Thway T; US FDA, Silver Spring, MD, USA., Woolf E; Merck Research Labs, West Point, PA, USA., Blaye OL; France ANSM, Saint Denis, France., Andisik M; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Briscoe C; PRA Health Sciences, Lenexa, KS, USA., Cape S; Covance, Madison, WI, USA., Dasgupta A; US FDA, Silver Spring, MD, USA., Fischer S; Genentech, South San Francisco, CA, USA., Haidar S; US FDA, Silver Spring, MD, USA., Hayes R; ICON, Whitesboro, NY, USA., Kamerud J; Pfizer, Andover, MA, USA., Lima Santos GM; Brazil ANVISA, Brasilia, Brazil., Nehls C; PPD, Richmond, VA, USA., Soo C; Health Canada, Ottawa, ON, Canada., Vinter S; UK MHRA, London, UK., Whale E; UK MHRA, London, UK., Xu K; Genentech, South San Francisco, CA, USA., Cho SJ; US FDA, Silver Spring, MD, USA., Edmison A; Health Canada, Ottawa, ON, Canada., Kassim S; US FDA, Silver Spring, MD, USA., Rocha TC; Brazil ANVISA, Brasilia, Brazil., Welink J; EMA, London, UK., Amur S; US FDA, Silver Spring, MD, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Cherry E; Health Canada, Ottawa, ON, Canada., Hopper S; UK MHRA-NIBSC, London, UK., Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan., Kirshner S; US FDA, Silver Spring, MD, USA., Maher K; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Saito Y; Japan MHLW-NIHS, Tokyo, Japan., Saunders TS; Norwegian Medicines Agency (NoMA), Oslo, Norway., Skibeli V; Norwegian Medicines Agency (NoMA), Oslo, Norway., Verthelyi D; US FDA, Silver Spring, MD, USA., Wang YM; US FDA, Silver Spring, MD, USA., Yan H; US FDA, Silver Spring, MD, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2019 Dec; Vol. 11 (23), pp. 2099-2132. Date of Electronic Publication: 2019 Dec 09.

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

Autor: Richards S; Sanofi, Framingham, MA, USA., Amaravadi L; Sanofi, Framingham, MA, USA., Pillutla R; Bristol-Myers Squibb, Princeton, NJ, USA., Birnboeck H; Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland., Torri A; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Cowan KJ; Genentech, South San Francisco, CA, USA., Papadimitriou A; Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany., Garofolo F; Angelini Pharma, Pomezia, RM, Italy., Satterwhite C; Charles River, Reno, NV, USA., Piccoli S; Bristol-Myers Squibb, Princeton, NJ, USA., Wu B; Janssen R&D, Spring House, PA, USA., Krinos-Fiorotti C; Bioagilytix Labs, Durham, NC, USA., Allinson J; LGC, Cambridge, UK., Berisha F; Daiichi Sankyo, Edison, NJ, USA., Cocea L; Health Canada, Ottawa, ON, Canada., Croft S; WHO, Geneva, Switzerland., Fraser S; Pfizer, Groton, CT, USA., Galliccia F; Italy AIFA, Rome, Italy., Gorovits B; Pfizer, Andover, MA, USA., Gupta S; Allergan, Irvine, CA, USA., Gupta V; Genentech, South San Francisco, CA, USA., Haidar S; US FDA, Silver Spring, MD, USA., Hottenstein C; GlaxoSmithKline, Paoli, PA, USA., Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan., Jani D; Pfizer, Andover, MA, USA., Kadavil J; US FDA, Silver Spring, MD, USA., Kamerud J; Eurofins Bioanalytical Services, St Charles, MO, USA., Kramer D; Sanofi, Frankfurt am Main, Germany., Litwin V; Covance, Indianapolis, IN, USA., Lima Santos GM; Brazil Anvisa, Brasilia, Brazil., Nelson R; Novimmune, Geneva, Switzerland., Ni Y; Bristol-Myers Squibb, Princeton, NJ, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Qiu Y; Shire, Lexington, MA, USA., Rhyne P; Q2 Solutions, Marietta, GA, USA., Safavi A; Bioagilytix Labs, Durham, NC, USA., Saito Y; Japan MHLW-NIHS, Tokyo, Japan., Savoie N; CFABS, Laval, QC, Canada., Scheibner K; US FDA, Silver Spring, MD, USA., Schick E; Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland., Siguenza PY; Genentech, South San Francisco, CA, USA., Smeraglia J; UCB Biopharma, Braine L'Alleud, Belgium., Staack RF; Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany., Subramanyam M; Biogen, Cambridge, MA, USA., Sumner G; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Thway T; Amgen, Thousand Oaks, CA, USA., Uhlinger D; Janssen R&D, Spring House, PA, USA., Ullmann M; EMD Serono, Aubonne, Switzerland., Vitaliti A; Novartis Pharma, Basel, Switzerland., Welink J; Dutch MEB, Utrecht, The Netherlands., Whiting CC; Aduro Biotech, Berkeley, CA, USA., Xue L; Pfizer, Andover, MA, USA., Zeng R; OncoMed Pharmaceuticals, Redwood City, CA, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2016 Dec; Vol. 8 (23), pp. 2475-2496.