Zobrazeno 1 - 10
of 11
pro vyhledávání: '"Abhari MR"'
Autor:
Mora J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Palmer R; Sanofi, Cambridge, MA, USA., Wagner L; US FDA, Silver Spring, MD, USA., Wu B; Janssen R&D, Spring House, PA, USA., Partridge M; Regeneron, Tarrytown, NY, USA., Meena; Stoke, Cambridge, MA, USA., Sonderegger I; Takeda, Opfikon, Switzerland., Smeraglia J; AstraZeneca, Cambridge, UK., Bivi N; Eli Lilly & Company, Indianapolis, IN, USA., Dakappagari N; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Diebold S; UK MHRA, London, UK., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Grimaldi C; Regeneron, Tarrytown, NY, USA., Kalina W; Pfizer, Groton, CT, USA., Kamerud J; Pfizer, Groton, CT, USA., Kar S; WRIB, Toronto, ON, Canada., Marshall JC; Moderna, Mystic, CT, USA., Mayer C; Austria AGES, Vienna, Austria., Melton A; BioMarin, Novato, CA, USA., Merdek K; Bristol Myers Squibb, Lawrenceville, NJ, USA., Nolan K; Merck, West Point, PA, USA., Picard S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Shao W; AstraZeneca, Cambridge, UK., Seitzer J; Intellia, Cambridge, MA, USA., Tanaka Y; Japan MHLW, Tokyo, Japan., Tounekti O; Health Canada, Ottawa, ON, Canada., Vigil A; Boehringer Ingelheim, Danbury, CT, USA., Walravens K; GlaxoSmithKline, Rixensart, Belgium., Xu J; US FDA, Jefferson, AR, USA.; Regenxbio, Rockville, MD, USA., Xu W; Merck, West Point, PA, USA., Xu Y; Intellia, Cambridge, MA, USA., Yang L; US FDA, Jefferson, AR, USA.; Regenxbio, Rockville, MD, USA., Zhu L; Moderna, Mystic, CT, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Kubiak RJ; AstraZeneca, Gaithersburg, MD, USA., Coble K; Boehringer Ingelheim, Danbury, CT, USA., Gupta S; AbbVie, Irvine, CA, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Richards S; Sanofi, Cambridge, MA, USA., Song Y; Genentech, South San Francisco, CA, USA., Ullmann M; Fresenius Kabi, Bad Homburg, Germany., Calderon B; Eli Lilly & Company, Indianapolis, IN, USA., Cludts I; UK MHRA, London, UK., Gunn GR; GlaxoSmithKline, Collegeville, PA, USA., Gupta S; Amgen, Thousand Oaks, CA, USA., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., McCush F; Pfizer, Groton, CT, USA., O'Day C; Seattle Genetics, Bothell, WA, USA., Peng K; Genentech, South San Francisco, CA, USA., Poetzl J; Sandoz, Oberhaching, Germany., Rasamoelisolo M; Sandoz, Oberhaching, Germany., Saad OM; Genentech, South San Francisco, CA, USA., Scheibner K; US FDA, Silver Spring, MD, USA., Shubow S; US FDA, Silver Spring, MD, USA., Song S; Takeda, Cambridge, MA, USA., Thacker S; US FDA, Silver Spring, MD, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2024 Apr; Vol. 16 (7), pp. 77-119. Date of Electronic Publication: 2024 Feb 22.
Autor:
Kholmanskikh O; Belgium FAMHP, Brussels, Belgium., Wang YM; US FDA, Silver Spring, MD, USA., Hersey S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Wadhwa M; UK MHRA, London, UK., Block K; Genentech, South San Francisco, CA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Szapacs M; Abbvie, Philadelphia, PA, USA., Weiner R; Takeda, Cambridge, MA, USA., Awwad K; Abbvie, Ludwigshafen, Germany., Dessy F; GlaxoSmithKline, Rixensart, Belgium.; Takeda, Cambridge, MA, USA., Downing S; Takeda, Cambridge, MA, USA., Du X; US FDA, Silver Spring, MD, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Harris S; HilleVax, Cambridge, MA, USA., Hou V; Moderna, Cambridge, MA, USA., Jones J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Kar S; WRIB, Toronto, ON, Canada., Kinhikar A; Novartis, Cambridge, MA, USA., Li M; Stoke, Cambridge, MA, USA., Mathews J; Ionis, Carlsbad, CA, USA., Meissen J; AstraZeneca, South San Francisco, CA, USA., Sumner GO; Regeneron, Tarrytown, NY, USA., Pan L; Takeda, Cambridge, MA, USA., Sanderink G; Sanofi Pasteur, Swiftwater, PA, USA., Scully I; Pfizer, Pearl River, NY, USA., Stanta J; Celerion, Stevenage, UK., Tanaka Y; Japan MHLW, Tokyo, Japan., Vauleon S; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Wagner L; US FDA, Silver Spring, MD, USA., Wang K; GlaxoSmithKline, Collegeville, PA, USA., Zhu L; Moderna, Cambridge, MA, USA., Eck S; AstraZeneca, Gaithersburg, MD, USA., Lin YD; Takeda, Cambridge, MA, USA., Azadeh M; Ultragenyx, Cambridge, MA, USA., Decman V; GlaxoSmithKline, Collegeville, PA, USA., Diebold S; UK MHRA, London, UK., Du X; US FDA, Silver Spring, MD, USA., Goihberg P; Pfizer, Andover, MA, USA., Alcaide EG; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Gonneau C; Labcorp, Meyrin, Switzerland., Hedrick MN; Bristol Myers Squibb, Lawrenceville, NJ, USA., Hopkins G; 2seventy Bio, Cambridge, MA, USA., Kar S; WRIB, Toronto, ON, Canada., Loschko J; Pfizer, Pearl River, NY, USA., McCausland M; Q2 Solutions, Atlanta. GA, USA., Mendez L; Merck, Kenilworth, NJ, USA., Sehra S; Incyte, Wilmington, DE, USA., Stevens E; Pfizer, Groton, CT, USA., Sun YS; Bristol Myers Squibb, Lawrenceville, NJ, USA., Tangri S; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Trampont PC; Moderna, Cambridge, MA, USA., Cludts I; UK MHRA, London, UK., Dysinger M; Alexion, New Haven, CT, USA., Kavita U; Spark Therapeutics, Plainsboro, NJ, USA., Sugimoto H; Takeda, Cambridge, MA, USA., Chilewski S; Bristol Myers Squibb, Lawrenceville, NJ, USA., Grimaldi C; Regeneron, Tarrytown, NY, USA., Jiang Y; GlaxoSmithKline, Collegeville, PA, USA., Kamerud J; Pfizer, Andover, MA, USA., Liu S; Pfizer, Kirkland, QC, Canada., Owen C; Pfizer, Groton, CT, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Petit-Frere C; Fresenius Kabi, Bad Homburg, Germany., Pine S; Sanofi, Ghent, Belgium., Abhari MR; US FDA, Silver Spring, MD, USA., Scheibner K; US FDA, Silver Spring, MD, USA., Williams L; Bristol Myers Squibb, Lawrenceville, NJ, USA., Xu T; Frontage, Exton, PA, USA., Zhang G; Alnylam, Cambridge, MA, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2024; Vol. 16 (8), pp. 179-220. Date of Electronic Publication: 2024 May 22.
Autor:
Baratta M; Takeda, Cambridge, MA, USA., Jian W; Johnson & Johnson Innovative Medicine, Spring House, PA, USA., Hengel S; Seattle Genetics, Bothell, WA, USA., Kaur S; Genentech, South San Francisco, CA, USA., Cunliffe J; Novartis, Cambridge, MA, USA., Boer J; Incyte, Wilmington, DE, USA., Hughes N; Biopharma, Toronto, ON, Canada., Kar S; WRIB, Toronto, ON, Canada., Kellie J; GlaxoSmithKline, Collegeville, PA, USA., Kim YJ; AstraZeneca, Gaithersburg, MD, USA., Lassman M; Merck & Co., Inc., Rahway, NJ, USA., Mehl J; GlaxoSmithKline, Collegeville, PA, USA., Morgan L; Moderna, Mystic, CT, USA., Palandra J; Takeda, Cambridge, MA, USA., Sarvaiya H; Abbvie, San Mateo, CA, USA., Zeng J; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Zheng N; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Wang J; Crinetics, San Diego, CA, USA., Yuan L; Biogen, Cambridge, MA, USA., Ji A; Chiesi, Boston, MA, USA., Kochansky C; Exelixis, Alameda, CA, USA., Tao L; Sanofi, Framingham, MA, USA., Huang Y; AstraZeneca, South San Francisco, CA, USA., Maes E; Abbvie, Chicago, IL, USA., Barbero L; EMD Serono, Ivrea, TO, Italy., Contrepois K; AstraZeneca, South San Francisco, CA, USA., Ferrari L; F. Hoffmann-La Roche Ltd, Roche Pharma Research & Early Development (pRED), Basel, Switzerland., Fu Y; Novartis, East Hanover, NJ, USA., Johnson J; Pfizer, Andover, MA, USA., Jones B; Crinetics, San Diego, CA, USA., Kansal M; Genentech, South San Francisco, CA, USA., Lu Y; US FDA, Silver Spring, MD, USA., Post N; Ionis, Carlsbad, CA, USA., Shen HH; Merck & Co., Inc., Rahway, NJ, USA., Xue YY; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Zhang YC; US FDA, Silver Spring, MD, USA., Biswas G; US FDA, Silver Spring, MD, USA., Cho SJ; US FDA, Silver Spring, MD, USA., Edmison A; Health Canada, Ottawa, ON, Canada., Benson K; US FDA, Silver Spring, MD, USA., Abberley L; GlaxoSmithKline, Collegeville, PA, USA., Azadeh M; Ultragenyx, Cambridge, MA, USA., Francis J; Regeneron, Tarrytown, NY, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Gupta S; Amgen, Thousand Oaks, CA, USA., Ivanova ID; Health Canada, Ottawa, ON, Canada., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Karnik S; Aliri, Colorado Springs, CO, USA., Kassim S; US FDA, Silver Spring, MD, USA., Kavetska O; Pfizer, Groton, CT, USA., Keller S; AbbVie, South San Francisco, CA, USA., Kossary E; WHO, Geneva, Switzerland., Li W; Novartis, East Hanover, NJ, USA., McCush F; Pfizer, Groton, CT, USA., Mendes DN; Brazil ANVISA, Brasilia, Brazil., Abhari MR; US FDA, Silver Spring, MD, USA., Scheibner K; US FDA, Silver Spring, MD, USA., Sikorski T; GlaxoSmithKline, Collegeville, PA, USA., Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Tabler E; PPD Thermo Fisher Scientific, Richmond, VA, USA., Tang H; GlaxoSmithKline, Collegeville, PA, USA., Wan K; Pfizer, San Diego, CA, USA., Wang YM; US FDA, Silver Spring, MD, USA., Whale E; UK MHRA, London, UK., Yang L; US FDA, Silver Spring, MD, USA., Zimmer J; Alturas Analytics, Moscow, ID, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Du X; US FDA, Silver Spring, MD, USA., Kholmanskikh O; Belgium FAMHP, Brussels, Belgium., Gijsel SK; Dutch IGJ, Randstad, Netherlands., Wadhwa M; UK MHRA, London, UK., Xu J; US FDA, Jefferson, AR, USA., Buoninfante A; EU EMA, Amsterdam, Netherlands., Cludts I; UK MHRA, London, UK., Diebold S; UK MHRA, London, UK., Maxfield K; US FDA, Silver Spring, MD, USA., Mayer C; Austria AGES, Vienna, Austria., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Shubow S; US FDA, Silver Spring, MD, USA., Tanaka Y; Japan MHLW, Tokyo, Japan., Tounekti O; Health Canada, Ottawa, ON, Canada., Verthelyi D; US FDA, Silver Spring, MD, USA., Wagner L; US FDA, Silver Spring, MD, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2024; Vol. 16 (9), pp. 307-364. Date of Electronic Publication: 2024 May 27.
Autor:
Szapacs M; Abbvie, Philadelphia, PA, USA., Jian W; Janssen, Spring House, PA, USA., Spellman D; Merck, West Point, PA, USA., Cunliffe J; Novartis, Cambridge, MA, USA., Verburg E; Lilly, Indianapolis, IN, USA., Kaur S; Genentech, South San Francisco, CA, USA., Kellie J; GlaxoSmithKline, Collegeville, PA, USA., Li W; Novartis, East Hanover, NJ, USA., Mehl J; GlaxoSmithKline, Collegeville, PA, USA., Qian M; Takeda, Cambridge, MA, USA., Qiu X; WRIB, Montreal, QC, Canada., Sirtori FR; EMD Serono, Ivrea, TO, Italy., Rosenbaum AI; AstraZeneca, South San Francisco, CA, USA., Sikorski T; GlaxoSmithKline, Collegeville, PA, USA., Surapaneni S; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Wang J; Crinetics, San Diego, CA, USA., Wilson A; AstraZeneca, Cambridge, UK., Zhang J; US FDA, Silver Spring, MD, USA., Xue Y; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Post N; Ionis, Carlsbad, CA, USA., Huang Y; AstraZeneca, South San Francisco, CA, USA., Goykhman D; Merck, West Point, PA, USA., Yuan L; Biogen, Cambridge, MA, USA., Fang K; GlaxoSmithKline, Collegeville, PA, USA., Casavant E; Genentech, South San Francisco, CA, USA., Chen L; Boehringer Ingelheim, Ridgefield, CT, USA., Fu Y; Novartis, East Hanover, NJ, USA., Huang M; Regeneron, Tarrytown, NY, USA., Ji A; Chiesi, Boston, MA, USA., Johnson J; Pfizer, Andover, MA, USA., Lassman M; Merck, West Point, PA, USA., Li J; Alnylam, Cambridge, MA, USA., Saad O; Genentech, South San Francisco, CA, USA., Sarvaiya H; Abbvie, San Mateo, CA, USA., Tao L; Sanofi, Framingham, MA, USA., Wang Y; WRIB, Montreal, QC, Canada., Zheng N; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Dasgupta A; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Saito Y; Japan MHLW, Tokyo, Japan., Mendes Fernandes DN; Brazil ANVISA, Brasilia, Brazil., Bower J; Precision for Medicine, Chantilly, VA, USA., Burns C; UK MHRA, London, UK., Carleton K; Janssen, Spring House, PA, USA., Cho SJ; US FDA, Silver Spring, MD, USA., Du X; US FDA, Silver Spring, MD, USA., Fjording M; EWG ICH M10, Copenhagen, Denmark., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Kar S; WRIB, Montreal, QC, Canada., Kavetska O; Pfizer, Groton, CT, USA., Kossary E; WHO, Geneva, Switzerland., Lu Y; US FDA, Silver Spring, MD, USA., Mayer A; GlaxoSmithKline, Collegeville, PA, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Salha D; Altasciences, Laval, QC, Canada., Thomas E; Labcorp, Indianapolis, IN, USA., Verhaeghe T; Janssen, Beerse, Belgium., Vinter S; UK MHRA, London, UK., Wan K; Pfizer, San Diego, CA, USA., Wang YM; US FDA, Silver Spring, MD, USA., Williams K; Genentech, South San Francisco, CA, USA., Woolf E; Merck, West Point, PA, USA., Yang L; US FDA, Silver Spring, MD, USA., Yang E; GlaxoSmithKline, Collegeville, PA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Hopper S; UK MHRA, London, UK., Maher K; US FDA, Silver Spring, MD, USA., Xu J; US FDA, Jefferson, AR, USA., Brodsky E; US FDA, Silver Spring, MD, USA., Cludts I; UK MHRA, London, UK., Irwin C; Health Canada, Ottawa, ON, Canada., Joseph J; Health Canada, Ottawa, ON, Canada., Kirshner S; US FDA, Silver Spring, MD, USA., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Solstad T; Norway NoMA, Oslo, Norway., Thacker S; US FDA, Silver Spring, MD, USA., Tounekti O; Health Canada, Ottawa, ON, Canada., Verthelyi D; US FDA, Silver Spring, MD, USA., Wadhwa M; UK MHRA, London, UK., Wagner L; US FDA, Silver Spring, MD, USA., Yamamoto T; Japan MHLW, Tokyo, Japan., Zhang L; Health Canada, Ottawa, ON, Canada., Zhou L; US FDA, Silver Spring, MD, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2023 Aug; Vol. 15 (16), pp. 955-1016. Date of Electronic Publication: 2023 Aug 31.
Autor:
Myler H; Bioanalytical and Biomarker Science and Technologies, Takeda, Cambridge, MA, 02139, USA. heather.myler@takeda.com.; 25 Creekview Ln, Yardley, Pennsylvania, 19067, USA. heather.myler@takeda.com., Pedras-Vasconcelos J; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20903, USA., Lester T; BioAgilytix Labs, Durham, North Carolina, 27713, USA., Civoli F; Coherus BioSciences, 333 Twin Dolphin Drive, Redwood City, California, 94065, USA., Xu W; Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA., Wu B; Bioanalytical Discovery and Development Sciences, Janssen Research and Development, Spring House, Pennsylvania, 19477, USA., Vainshtein I; Discovery and Translational Research, Exelixis, 1851 Harbor Bay Pkwy, Alameda, California, 94502, USA., Luo L; Regulated Global Bioanalytics, Merck & Co., Inc, Rahway, New Jersey, 07065, USA., Hassanein M; Early Clinical Development, Precision Medicine, Pfizer Inc, Cambridge, Massachusetts, USA., Liu S; Global Product Development, , Pfizer Inc, 17300 Trans Canada Hwy, Kirkland, Quebec, Canada., Ramaswamy SS; Regulated Bioanalysis Department, B2S Life Sciences, 97 East Monroe Street, Franklin, Indiana, 46131, USA., Mora J; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Pennucci J; Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA., McCush F; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA., Lavelle A; Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Jani D; Preclinical and Clinical Bioanalysis, , Moderna Tx, 200 Technology Square, Cambridge, Massachusetts, 02142, USA., Ambakhutwala A; Immunology Sciences, Kriya Therapeutics, 4105 Hopson Road, Morrisville, North Carolina, 27560, USA., Baltrukonis D; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA., Barker B; Drug Metabolism and Biopharmaceuticals, Incyte Corporation, 1801 Augustine Cut-Off, Wilmington, Delaware, 19803, USA., Carmean R; Bioanalytical Lab, PPD Clinical Research, , 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Chung S; Department of BioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA., Dai S; Quantitative Clinical Pharmacology & Translational Sciences (QCP), Daiichi Sankyo, Inc, 211 Mt. Airy Road, Basking Ridge, New Jersey, 07920, USA., DeWall S; Bioanalytical Sciences, Scholar Rock, 301 Binney Street, 3rd Floor, Cambridge, Massachusetts, 02142-1071, USA., Dholakiya SL; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Dodge R; Novartis Institutes for BioMedical Research, 1 Health Plaza, East Hanover, New Jersey, 07936, USA., Finco D; Deborah Finco Consulting LLC, 101 Prospect Hill Road, Groton, Connecticut, 06340, USA., Yan H; Global Regulatory Affairs, Shanghai Henlius Biotech. Inc, 430 N. McCarthy Blvd, Milpitas, California, 95035, USA., Hays A; BioAgilytix Labs, Durham, North Carolina, 27713, USA., Hu Z; Translation Safety & Bioanalytical Science, Amgen Inc, Thousand Oaks, California, 91360, USA., Inzano C; Non-Clinical Disposition and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA., Kamen L; BioAgilytix Labs, Durham, North Carolina, 27713, USA., Lai CH; Bioanalytical Sciences, Regeneron Pharmaceuticals, Tarrytown, New York, USA., Meyer E; Immunogenicity, GSK Pharmaceuticals, 1250 South Collegeville Road, Collegeville, Pennsylvania, 19426, USA., Nelson R; Bioanalytical Services, Labcorp Drug Development, Otley Road, Harrogate, HG3 1PY, UK., Paudel A; Research Center Pharmaceutical Engineering GmbH (RCPE), Inffeldgasse 13, 8010, Graz, Austria., Phillips K; Clinical Pharmacology, Pfizer Inc, Eastern Point Road, Groton, CT, 06379, USA., Poupart ME; Immunology, Charles River Laboratories, Montreal ULC, Transcanada Highway, Senneville, Quebec, 22022, Canada., Qu Q; Quantitative Bioanalytics, Moderna, 200 Technology Square, Cambridge, Massachusetts, 02139, USA., Abhari MR; Office of Clinical PharmacologyOffice of Translational SciencesCenter for Drugs Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20903, USA., Ryding J; Bioanalysis-Biologics, Lundbeck A/S, Ottiliavej 9, 2500, Valby, Denmark., Sheldon C; Technical Operations, , IVERIC Bio, Inc, 8 Sylvan Way, Parsippany, New Jersey, 07054, USA., Spriggs F; Spriggs Bioanalytical Consulting LLC, 15632 W 83rd Terrace, Lenexa, Kansas, 66219, USA., Warrino D; Bioanalytical and Biomarker Services, KCAS, 10830 S Clay Blair Blvd, Olathe, Kansas, 66061, USA., Wu Y; Integrated Bioanalysis, , AstraZeneca, Gaithersburg, Maryland, 20878, USA., Yang L; Bioanalytical Sciences, REGENXBIO Inc, 9804 Medical Center Drive, Rockville, Maryland, 20850, USA., Pasas-Farmer S; BioData Solutions, 1021 ½ Massachusetts Street, Lawrence, Kansas, 66044, USA.
Publikováno v:
The AAPS journal [AAPS J] 2023 Jul 08; Vol. 25 (4), pp. 69. Date of Electronic Publication: 2023 Jul 08.
Autor:
Pan L; Takeda, Cambridge, MA, USA., Mora J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Walravens K; GlaxoSmithKline, Rixensart, Belgium., Wagner L; US FDA, Silver Spring, MD, USA., Hopper S; UK MHRA, London, UK., Loo L; Vertex, Boston, MA, USA., Bettoun D; Larimar, Bala-Cynwyd, PA, USA., Bond S; Alnylam, Cambridge, MA, USA., Dessy F; GlaxoSmithKline, Rixensart, Belgium., Downing S; Takeda, Cambridge, MA, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Gupta S; BioMarin, Novato, CA, USA., Henderson N; AstraZeneca, Gothenburg, Sweden., Irwin C; Health Canada, Ottawa, ON, Canada., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Kar S; WRIB, Montreal, QC, Canada., Jawa V; Bristol Myers Squibb, Lawrenceville, NJ, USA., Joseph J; Health Canada, Ottawa, ON, Canada., Malvaux L; GlaxoSmithKline, Rixensart, Belgium., Marshall JC; Moderna, Mystic, CT, USA., McDevitt J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Mohapatra S; Stoke, Cambridge, MA, USA., Seitzer J; Intellia, Cambridge, MA, USA., Smith J; Pfizer, Groton, CT, USA., Solstad T; Norway NoMA, Oslo, Norway., Sugimoto H; Takeda, Cambridge, MA, USA., Tounekti O; Health Canada, Ottawa, ON, Canada., Wu B; Janssen R&D, Spring House, PA, USA., Wu Y; AstraZeneca, Gaithersburg, MD, USA., Xu Y; Intellia, Cambridge, MA, USA., Xu J; US FDA, Jefferson, AR, USA., Yamamoto T; Japan MHLW, Tokyo, Japan., Yang L; REGENXBIO, Rockville, MD, USA., Torri A; Regeneron, Tarrytown, NY, USA., Kirshner S; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Vasconcelos JP; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Brodsky E; US FDA, Silver Spring, MD, USA., Carrasco-Triguero M; Sangamo, Brisbane, CA, USA., Kamerud J; Pfizer, Groton, CT, USA., Andisik M; Regeneron, Tarrytown, NY, USA., Baltrukonis D; Pfizer, Groton, CT, USA., Bivi N; Lilly, Indianapolis, IN, USA., Cludts I; UK MHRA, London, UK., Coble K; Boehringer Ingelheim, Danbury, CT, USA., Gorovits B; Sana Bio, Cambridge, MA, USA., Gunn GR; GSK, Collegeville, PA, USA., Gupta S; AbbVie, Irvine, CA, USA., Millner AH; Novo Nordisk, Maaloev, Denmark., Joyce A; Pfizer, Groton, CT, USA., Kubiak RJ; AstraZeneca, Gaithersburg, MD, USA., Kumar S; EMD Serono, Boston, MA, USA., Liao K; Merck, West Point, PA, USA., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Partridge M; Regeneron, Tarrytown, NY, USA., Pine S; Sanofi, Ghent, Belgium., Poetzl J; Sandoz, Oberhaching, Germany., Rajadhyaksha M; Alexion, New Haven, CT, USA., Rasamoelisolo M; Teva, West Chester, PA, USA., Richards S; Sanofi, Framingham, MA, USA., Song Y; Genentech, South San Francisco, CA, USA., Swanson S; Genentech, South San Francisco, CA, USA., Thacker S; US FDA, Silver Spring, MD, USA., Wadhwa M; UK MHRA, London, UK., Wolf A; Amgen, Munich, Germany., Zhang L; Health Canada, Ottawa, ON, Canada., Zhou L; US FDA, Silver Spring, MD, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2023 Jul; Vol. 15 (14), pp. 773-814. Date of Electronic Publication: 2023 Aug 01.
Autor:
Loo L; Vertex, Boston, MA., Harris S; HilleVax, Cambridge, MA, USA., Milton M; Novartis, Cambridge, MA, USA., Meena; Stoke, Cambridge, MA, USA., Lembke W; UCB Farchim SA, Bulle, Switzerland., Berisha F; Janssen R&D, Spring House, PA, USA., Bertholet S; GlaxoSmithKline Vaccines, Rockville, MD, USA., Dessy F; GlaxoSmithKline, Rixensart, Belgium., Dodge R; Novartis, East Hanover, NJ, USA., Fang X; AskBio, Research Triangle Park, NC, USA., Fiscella M; REGENXBIO, Rockville, MD, USA., Garofolo F; BRI - a Frontage company, Vancouver, BC, Canada., Gorovits B; Sana Bio, Cambridge, MA, USA., Gupta S; BioMarin, Novato, CA, USA., Jawa V; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan., Long B; BioMarin, Novato, CA, USA., Lu Y; Sangamo, Brisbane, CA, USA., Mack T; Bristol-Myers Squibb, Lawrenceville, NJ, USA., McGuire K; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Nolan K; Merck, West Point, PA, USA., Pan L; Takeda, Cambridge, MA, USA., Potthoff B; Novartis, Basel, Switzerland., Purushothama S; WRIB, Montreal, QC, Canada., Smith D; Health Canada, Ottawa, ON, Canada., Solstad T; Norwegian Medicines Agency, Oslo, Norway., Sonderegger I; Takeda, Opfikon, Switzerland., Taddeo F; Takeda, Cambridge, MA, USA., Tangri S; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Wagner L; US FDA, Silver Spring, MD, USA., Wu B; Janssen R&D, Spring House, PA, USA., Xu Y; Intellia, Cambridge, MA, USA., Kirshner S; US FDA, Silver Spring, MD, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Yan H; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Gupta S; AbbVie, Irvine, CA, USA., Wu Y; AstraZeneca, Gaithersburg, MD, USA., Rajadhyaksha M; Alexion, New Haven, CT, USA., Andisik M; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Baltrukonis D; Pfizer, Groton, CT, USA., Cherry E; Health Canada, Ottawa, ON, Canada., Cludts I; UK MHRA, London, UK., Gunn G; GlaxoSmithKline, Collegeville, PA, USA., Millner AH; Novo Nordisk, Maaloev, Denmark., Jordan G; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Kar S; WRIB, Montreal, QC, Canada., Kubiak R; AstraZeneca, Gaithersburg, MD, USA., Lotz GP; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Palmer R; Sanofi, Framingham, MA, USA., Peng K; Genentech, South San Francisco, CA, USA., Poetzl J; Sandoz, Oberhaching, Germany., Richards S; Sanofi, Framingham, MA, USA., Savoie N; WRIB, Montreal, QC, Canada., Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Stubenrauch K; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Wadhwa M; UK MHRA, London, UK., Waxenecker G; Austria AGES, Vienna, Austria., Yang TY; Janssen R&D, Spring House, PA, USA., Zhang L; Health Canada, Ottawa, ON, Canada.
Publikováno v:
Bioanalysis [Bioanalysis] 2022 Jun; Vol. 14 (11), pp. 737-793. Date of Electronic Publication: 2022 May 17.
Autor:
Kaur S; Genentech, South San Francisco, CA, USA., Alley SC; Seattle Genetics, Bothell, WA, USA., Szapacs M; Abbvie, Philadelphia, PA, USA., Wilson A; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK., Ciccimaro E; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Su D; Mersana, Cambridge, MA, USA., Henderson N; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Chen L; Boehringer Ingelheim, Ridgefield, CT, USA., Garofolo F; BRI - a Frontage Company, Vancouver, BC, Canada., Hengel S; Seattle Genetics, Bothell, WA, USA., Jian W; Janssen Research & Development, Spring House, PA, USA., Kellie JF; GlaxoSmithKline, Collegeville, PA, USA., Lee A; Merck, Kenilworth, NJ, USA., Mehl J; GlaxoSmithKline, Collegeville, PA, USA., Palandra J; Pfizer, Andover, MA, USA., Qiu H; Regeneron, Tarrytown, NY, USA., Savoie N; WRIB, Montreal, QC, Canada., Shakleya D; US FDA, Silver Spring, MD, USA., Staelens L; UCB, Braine l'Alleud, Belgium., Sugimoto H; Takeda, Cambridge, MA, USA., Sumner G; Regeneron, Tarrytown, NY, USA., Welink J; EU EMA, Amsterdam, Netherlands., Wheller R; LGC, Fordham, UK., Xue YJ; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Zeng J; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Zhang J; US FDA, Silver Spring, MD, USA., Zhou H; BioMarin, Novato, CA, USA., Wang J; Crinetics, San Diego, CA, USA., Summerfield S; GlaxoSmithKline, Stevenage, UK., Kavetska O; Pfizer, Groton, CT, USA., Dillen L; Janssen Research & Development, Beerse, Belgium., Ramanathan R; Vertex, Boston, MA., Baratta M; Takeda, Cambridge, MA, USA., Dasgupta A; US FDA, Silver Spring, MD, USA., Edmison A; Health Canada, Ottawa, ON, Canada., Ferrari L; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Fischer S; Genentech, South San Francisco, CA, USA., Fraier D; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Haidar S; US FDA, Silver Spring, MD, USA., Heermeier K; Sanofi, Frankfurt, Germany., James C; Amgen Research, Thousand Oaks, CA, USA., Ji A; Sanofi, Framingham, MA, USA., Luo L; Pfizer, Groton, CT, USA., Lima Santos GM; Brazil ANVISA, Brasilia, Brazil., Post N; Ionis, Carlsbad, CA, USA., Rosenbaum AI; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA., Sporring S; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA., Surapaneni S; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Vinter S; Novo Nordisk, Maaloev, Denmark., Wan K; Pfizer, Groton, CT, USA., Woolf E; UK MHRA, London, UK., Kavetska O; Pfizer, Groton, CT, USA., Cho SJ; US FDA, Silver Spring, MD, USA., Kossary E; WHO, Geneva, Switzerland., Prior S; UK MHRA, London, UK., Abhari MR; US FDA, Silver Spring, MD, USA., Soo C; Health Canada, Ottawa, ON, Canada., Wang YM; US FDA, Silver Spring, MD, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Cherry E; Health Canada, Ottawa, ON, Canada., Cludts I; UK MHRA, London, UK., Ghosh S; US FDA, Silver Spring, MD, USA., Hopper S; UK MHRA, London, UK., Ishii-Watabe A; WHO, Geneva, Switzerland., Kirshner S; US FDA, Silver Spring, MD, USA., Maher K; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Saito Y; Japan MHLW, Tokyo, Japan., Smith D; Health Canada, Ottawa, ON, Canada., Solstad T; Norway NoMA, Oslo, Norway., Verthelyi D; US FDA, Silver Spring, MD, USA., Wadhwa M; UK MHRA, London, UK., Wagner L; US FDA, Silver Spring, MD, USA., Waxenecker G; Austria AGES, Vienna, Austria., Yan H; US FDA, Silver Spring, MD, USA., Zhang L; Health Canada, Ottawa, ON, Canada.
Publikováno v:
Bioanalysis [Bioanalysis] 2022 May; Vol. 14 (9), pp. 505-580. Date of Electronic Publication: 2022 May 17.
Autor:
Hersey S; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Keller S; AbbVie, South San Francisco, CA, USA., Mathews J; Ionis, Carlsbad, CA, USA., King L; Pfizer, Cambridge, MA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Berisha F; Janssen R&D, Spring House, PA, USA., Birchler M; GlaxoSmithKline, Collegeville, PA, USA., Bower J; Precision for Medicine, Bethesda, MD, USA., Clausen V; Alnylam, Cambridge, MA, USA., Duarte J; F. Hoffmann-La Roche, Basel, Switzerland., Garofolo F; BRI - a Frontage Company, Vancouver, BC, Canada., Hopper S; UK MHRA, London, UK., Kar S; WRIB, Montreal, QC, Canada., Mabrouk O; Biogen, Cambridge, MA, USA., Marshall JC; Moderna, Cambridge, MA, USA., McGuire K; Regeneron, Tarrytown, NY, USA., Naughton M; GlaxoSmithKline, Stevenage, UK., Saito Y; Japan MHLW-NIHS, Tokyo, Japan., Schuhmann I; Novartis, Basel, Switzerland., Sperinde G; Genentech, South San Francisco, CA, USA., Teixeira P; F. Hoffmann-La Roche, Basel, Switzerland., Vitaliti A; Novartis, Basel, Switzerland., Wang YM; US FDA, Silver Spring, MD, USA., Wnek R; Merck, Kenilworth, NJ, USA., Zhang Y; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Spitz S; Incyte Research Institute, Wilmington, DE, USA., Decman V; GlaxoSmithKline, Philadelphia, PA, USA., Eck S; AstraZeneca, Gaithersburg, MD, USA., Estevam J; Takeda, Cambridge, MA, USA., Goihberg P; Pfizer, Andover, MA, USA., Alcaide EG; F. Hoffmann-La Roche, Basel, Switzerland., Gonneau C; Labcorp, Meyrin, Switzerland., Hedrick MN; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Hopkins G; Bluebird Bio, Cambridge, MA, USA., Junker F; F. Hoffmann-La Roche, Basel, Switzerland., Nuti S; GSK vaccines, Rockville, MD, USA., Sommer U; Novartis, Basel, Switzerland., Standifer N; AstraZeneca, South San Francisco, CA, USA., Stevens C; Pfizer, Cambridge, MA, USA., Stevens E; Pfizer, Groton, CT, USA., Hendricks C; Sanofi, Framingham, MA, USA., Wadhwa M; UK MHRA, London, UK., Torri A; Regeneron, Tarrytown, NY, USA., Ma M; Alexion, New Haven, CT, USA., Harris S; HilleVax, Cambridge, MA, USA., Kumar S; EMD Serono, Andover, MA, USA., Partridge MA; Regeneron, Tarrytown, NY, USA., Caiazzo T; Pfizer, Cambridge, MA, USA., Chilewski S; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Cludts I; UK MHRA, London, UK., Coble K; Boehringer Ingelheim, Ridgefield, CT, USA., Gorovits B; Sana Bio, Cambridge, MA, USA., Grimaldi C; Boehringer Ingelheim, Ridgefield, CT, USA., Jordan G; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Kamerud J; Pfizer, Cambridge, MA, USA., Leary B; Pfizer, Cambridge, MA, USA., Liang M; AstraZeneca, South San Francisco, CA, USA., Lim H; Genentech, South San Francisco, CA, USA., Mayer A; GlaxoSmithKline, Collegeville, PA, USA., O'Connor E; AstraZeneca, Gaithersburg, MD, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Poetzl J; Sandoz, Munich, Germany., Prior S; UK MHRA, London, UK., Abhari MR; US FDA, Silver Spring, MD, USA., Savoie N; WRIB, Montreal, QC, Canada., Soo C; Health Canada, Ottawa, ON, Canada., Ware M; Janssen R&D, Spring House, PA, USA., Wu B; Janssen R&D, Spring House, PA, USA., Xu Y; Merck, West Point, PA, USA., Yang TY; Janssen R&D, Spring House, PA, USA., Zoghbi J; Sanofi, Framingham, MA, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2022 May; Vol. 14 (10), pp. 627-692. Date of Electronic Publication: 2022 May 17.
Autor:
Corsaro B; GlaxoSmithKline, Rockville, MD, USA., Yang TY; Janssen R&D, Spring House, PA, USA., Murphy R; Merck, West Point, PA, USA., Sonderegger I; Takeda, Opfikon, Switzerland., Exley A; UK MHRA, London, UK., Bertholet S; GlaxoSmithKline, Rockville, MD, USA., Dakappagari N; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Dessy F; GlaxoSmithKline, Rixensart, Belgium., Garofolo F; BRI, Vancouver, BC, Canada., Kierstead L; PPD, Wayne, PA, USA., Koch H; Takeda, Opfikon, Switzerland., Sarikonda G; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Savoie N; CFABS, Montreal, QC, Canada., Siggers R; Health Canada, Ottawa, ON, Canada., Solstad T; Norwegian Medicines Agency, Oslo, Norway., Lu Y; Sangamo Therapeutics, Brisbane, CA, USA., Milton M; Novartis, Cambridge, MA, USA., Marshall JC; Pfizer, Groton, CT, USA., DelCarpini J; bluebird bio, Cambridge, MA, USA., Gorovits B; Pfizer, Andover, MA, USA., Gupta S; Abbvie, Irvine, CA, USA., Jesaitis L; BioMarin, Novato, CA, USA., Kamerud J; Pfizer, Andover, MA, USA., Kromminga A; BioAgilytix, Hamburg, Germany., Ma A; CRISPR Therapeutics, Cambridge, MA, USA., McNally J; BioAgilytix, Durham, NC, USA., Yan H; US FDA, Silver Spring, MD, USA., Wu B; Janssen R&D, Spring House, PA, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Kirshner S; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Rajadhyaksha M; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Cherry E; Health Canada, Ottawa, ON, Canada., Cludts I; UK MHRA-NIBSC, London, UK., Dahlbäck M; Novo Nordisk, Maaloev, Denmark., Gunn GR; GlaxoSmithKline, Collegeville, PA, USA., Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan., Jawa V; Merck, Kenilworth, NJ, USA., Kubiak R; AstraZeneca, Gaithersburg, MD, USA., Partridge M; Regeneron Pharmaceuticals, Tarrytown, NY, USA., Petrillo M; Biogen, Cambridge, MA, USA., Pine SO; Ablynx, Zwijnaarde, Belgium., Poetzl J; Hexal AG, Oberhaching, Germany., Song S; Takeda, Cambridge, MA, USA., Stebbins C; Immunologix Labs, Tampa, FL, USA., Wu Y; AstraZeneca, Gaithersburg, MD, USA., Zhang L; Health Canada, Ottawa, ON, Canada., Kar S; CFABS, Montreal, QC, Canada., Liang M; AstraZeneca, South San Francisco, CA, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Schweighardt B; BioMarin, Novato, CA, USA., Stubenrauch K; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Xu Y; Intellia Therapeutics, Cambridge, MA, USA.
Publikováno v:
Bioanalysis [Bioanalysis] 2021 Mar; Vol. 13 (6), pp. 415-463. Date of Electronic Publication: 2021 Feb 03.