换一批2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & <u>Part 1B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
第一作者：
Surinder,Kaur
第一单位：
Genentech, South San Francisco, CA, USA.
作者：
Surinder,Kaur [1]
;
Stephen C,Alley [2]
;
Matt,Szapacs [3]
;
Amanda,Wilson [4]
;
Eugene,Ciccimaro [5]
;
Dian,Su [6]
;
Neil,Henderson [7]
;
Linzhi,Chen [8]
;
Fabio,Garofolo [9]
;
Shawna,Hengel [2]
;
Wenying,Jian [10]
;
John F,Kellie [11]
;
Anita,Lee [12]
;
John,Mehl [11]
;
Joe,Palandra [13]
;
Haibo,Qiu [14]
;
Natasha,Savoie [15]
;
Diaa,Shakleya [16]
;
Ludovicus,Staelens [17]
;
Hiroshi,Sugimoto [18]
;
Giane,Sumner [14]
;
Jan,Welink [19]
;
Robert,Wheller [20]
;
Y-J,Xue [5]
;
Jianing,Zeng [5]
;
Jinhui,Zhang [16]
;
Huiyu,Zhou [21]
;
Jian,Wang [22]
;
Scott,Summerfield [23]
;
Olga,Kavetska [24]
;
Lieve,Dillen [25]
;
Ragu,Ramanathan [26]
;
Mike,Baratta [18]
;
Arindam,Dasgupta [16]
;
Anna,Edmison [27]
;
Luca,Ferrari [28]
;
Sally,Fischer [1]
;
Daniela,Fraier [28]
;
Sam,Haidar [16]
;
Kathrin,Heermeier [29]
;
Christopher,James [30]
;
Allena,Ji [31]
;
Lina,Luo [24]
;
Gustavo Mendes,Lima Santos [32]
;
Noah,Post [33]
;
Anton I,Rosenbaum [34]
;
Sune,Sporring [34]
;
Sekhar,Surapaneni [5]
;
Stephen,Vinter [35]
;
Katty,Wan [24]
;
Eric,Woolf [36]
;
Olga,Kavetska [24]
;
Seongeun Julia,Cho [16]
;
Elham,Kossary [37]
;
Sandra,Prior [36]
;
Mohsen Rajabi,Abhari [16]
;
Catherine,Soo [27]
;
Yow-Ming,Wang [16]
;
Abbas,Bandukwala [16]
;
Elana,Cherry [27]
;
Isabelle,Cludts [36]
;
Soma,Ghosh [16]
;
Shirley,Hopper [36]
;
Akiko,Ishii-Watabe [37]
;
Susan,Kirshner [16]
;
Kevin,Maher [16]
;
Kimberly,Maxfield [16]
;
Joao,Pedras-Vasconcelos [16]
;
Yoshiro,Saito [38]
;
Dean,Smith [27]
;
Therese,Solstad [39]
;
Daniela,Verthelyi [16]
;
Meenu,Wadhwa [36]
;
Leslie,Wagner [16]
;
Günter,Waxenecker [40]
;
Haoheng,Yan [16]
;
Lucia,Zhang [27]
作者单位：
Genentech, South San Francisco, CA, USA.
[1]
Seattle Genetics, Bothell, WA, USA.
[2]
Abbvie, Philadelphia, PA, USA.
[3]
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
[4]
Bristol-Myers Squibb, Lawrenceville, NJ, USA.
[5]
Mersana, Cambridge, MA, USA.
[6]
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
[7]
Boehringer Ingelheim, Ridgefield, CT, USA.
[8]
BRI - a Frontage Company, Vancouver, BC, Canada.
[9]
Janssen Research & Development, Spring House, PA, USA.
[10]
GlaxoSmithKline, Collegeville, PA, USA.
[11]
Merck, Kenilworth, NJ, USA.
[12]
Pfizer, Andover, MA, USA.
[13]
Regeneron, Tarrytown, NY, USA.
[14]
WRIB, Montreal, QC, Canada.
[15]
US FDA, Silver Spring, MD, USA.
[16]
UCB, Braine l'Alleud, Belgium.
[17]
Takeda, Cambridge, MA, USA.
[18]
EU EMA, Amsterdam, Netherlands.
[19]
LGC, Fordham, UK.
[20]
BioMarin, Novato, CA, USA.
[21]
Crinetics, San Diego, CA, USA.
[22]
GlaxoSmithKline, Stevenage, UK.
[23]
Pfizer, Groton, CT, USA.
[24]
Janssen Research & Development, Beerse, Belgium.
[25]
Vertex, Boston, MA.
[26]
Health Canada, Ottawa, ON, Canada.
[27]
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
[28]
Sanofi, Frankfurt, Germany.
[29]
Amgen Research, Thousand Oaks, CA, USA.
[30]
Sanofi, Framingham, MA, USA.
[31]
Brazil ANVISA, Brasilia, Brazil.
[32]
Ionis, Carlsbad, CA, USA.
[33]
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA.
[34]
Novo Nordisk, Maaloev, Denmark.
[35]
UK MHRA, London, UK.
[36]
WHO, Geneva, Switzerland.
[37]
Japan MHLW, Tokyo, Japan.
[38]
Norway NoMA, Oslo, Norway.
[39]
Austria AGES, Vienna, Austria.
[40]
DOI
10.4155/bio-2022-0078
PMID
35578993
发布时间
2025-12-12
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Bioanalysis
Bioanalysis
505-580页
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