换一批2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (<u>Part 1A</u> - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
第一作者：
Matt,Szapacs
第一单位：
Abbvie, Philadelphia, PA, USA.
作者：
Matt,Szapacs [1]
;
Wenying,Jian [2]
;
Daniel,Spellman [3]
;
Jennifer,Cunliffe [4]
;
Elizabeth,Verburg [5]
;
Surinder,Kaur [6]
;
John,Kellie [7]
;
Wenkui,Li [8]
;
John,Mehl [7]
;
Mark,Qian [9]
;
Xiazi,Qiu [10]
;
Federico Riccardi,Sirtori [11]
;
Anton I,Rosenbaum [12]
;
Tim,Sikorski [7]
;
Sekhar,Surapaneni [13]
;
Jian,Wang [14]
;
Amanda,Wilson [15]
;
Jinhui,Zhang [16]
;
Yongjun,Xue [13]
;
Noah,Post [17]
;
Yue,Huang [12]
;
Dina,Goykhman [3]
;
Long,Yuan [18]
;
Kasie,Fang [7]
;
Ellen,Casavant [6]
;
Linzhi,Chen [19]
;
Yunlin,Fu [8]
;
Ming,Huang [20]
;
Allena,Ji [21]
;
Jay,Johnson [22]
;
Michael,Lassman [3]
;
Jing,Li [23]
;
Ola,Saad [6]
;
Hetal,Sarvaiya [24]
;
Lin,Tao [25]
;
Yuting,Wang [10]
;
Naiyu,Zheng [13]
;
Arindam,Dasgupta [16]
;
Mohsen Rajabi,Abhari [16]
;
Akiko,Ishii-Watabe [26]
;
Yoshiro,Saito [26]
;
Dulcyane Neiva,Mendes Fernandes [27]
;
Joseph,Bower [28]
;
Chris,Burns [29]
;
Kevin,Carleton [2]
;
Seongeun Julia,Cho [16]
;
Xiulian,Du [16]
;
Marianne,Fjording [30]
;
Fabio,Garofolo [31]
;
Sumit,Kar [10]
;
Olga,Kavetska [32]
;
Elham,Kossary [33]
;
Yang,Lu [16]
;
Andrew,Mayer [7]
;
Nisha,Palackal [20]
;
Danielle,Salha [34]
;
Eric,Thomas [35]
;
Tom,Verhaeghe [36]
;
Stephen,Vinter [29]
;
Katty,Wan [37]
;
Yow-Ming,Wang [16]
;
Kathi,Williams [6]
;
Eric,Woolf [3]
;
Li,Yang [16]
;
Eric,Yang [7]
;
Abbas,Bandukwala [16]
;
Shirley,Hopper [29]
;
Kevin,Maher [16]
;
Joshua,Xu [38]
;
Eric,Brodsky [16]
;
Isabelle,Cludts [29]
;
Chad,Irwin [39]
;
Julie,Joseph [39]
;
Susan,Kirshner [16]
;
Mohanraj,Manangeeswaran [16]
;
Kimberly,Maxfield [16]
;
Joao,Pedras-Vasconcelos [16]
;
Therese,Solstad [40]
;
Seth,Thacker [16]
;
Omar,Tounekti [39]
;
Daniela,Verthelyi [16]
;
Meenu,Wadhwa [29]
;
Leslie,Wagner [16]
;
Takenori,Yamamoto [26]
;
Lucia,Zhang [39]
;
Lin,Zhou [16]
作者单位：
Abbvie, Philadelphia, PA, USA.
[1]
Janssen, Spring House, PA, USA.
[2]
Merck, West Point, PA, USA.
[3]
Novartis, Cambridge, MA, USA.
[4]
Lilly, Indianapolis, IN, USA.
[5]
Genentech, South San Francisco, CA, USA.
[6]
GlaxoSmithKline, Collegeville, PA, USA.
[7]
Novartis, East Hanover, NJ, USA.
[8]
Takeda, Cambridge, MA, USA.
[9]
WRIB, Montreal, QC, Canada.
[10]
EMD Serono, Ivrea, TO, Italy.
[11]
AstraZeneca, South San Francisco, CA, USA.
[12]
Bristol-Myers Squibb, Lawrenceville, NJ, USA.
[13]
Crinetics, San Diego, CA, USA.
[14]
AstraZeneca, Cambridge, UK.
[15]
US FDA, Silver Spring, MD, USA.
[16]
Ionis, Carlsbad, CA, USA.
[17]
Biogen, Cambridge, MA, USA.
[18]
Boehringer Ingelheim, Ridgefield, CT, USA.
[19]
Regeneron, Tarrytown, NY, USA.
[20]
Chiesi, Boston, MA, USA.
[21]
Pfizer, Andover, MA, USA.
[22]
Alnylam, Cambridge, MA, USA.
[23]
Abbvie, San Mateo, CA, USA.
[24]
Sanofi, Framingham, MA, USA.
[25]
Japan MHLW, Tokyo, Japan.
[26]
Brazil ANVISA, Brasilia, Brazil.
[27]
Precision for Medicine, Chantilly, VA, USA.
[28]
UK MHRA, London, UK.
[29]
EWG ICH M10, Copenhagen, Denmark.
[30]
BRI Frontage, Vancouver, BC, Canada.
[31]
Pfizer, Groton, CT, USA.
[32]
WHO, Geneva, Switzerland.
[33]
Altasciences, Laval, QC, Canada.
[34]
Labcorp, Indianapolis, IN, USA.
[35]
Janssen, Beerse, Belgium.
[36]
Pfizer, San Diego, CA, USA.
[37]
US FDA, Jefferson, AR, USA.
[38]
Health Canada, Ottawa, ON, Canada.
[39]
Norway NoMA, Oslo, Norway.
[40]
医学主题词
色谱法(Chromatography);疫苗(Vaccines);质谱分析法(Mass Spectrometry);寡核苷酸类(Oligonucleotides);工艺学(Technology)
DOI
10.4155/bio-2023-0167
PMID
37650500
发布时间
2025-12-12
- 浏览0
Bioanalysis
Bioanalysis
955-1016页
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