2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (

Chromatography Vaccines Biomarkers Cell- and Tissue-Based Therapy Mass Spectrometry Oligonucleotides Technology
WRIB bioanalysis biomarkers cell therapy gene therapy immunogenicity vaccine

Journal

Bioanalysis
ISSN: 1757-6199
Titre abrégé: Bioanalysis
Pays: England
ID NLM: 101512484

Informations de publication

Date de publication:
Aug 2023
Historique:
medline: 7 9 2023
pubmed: 31 8 2023
entrez: 31 8 2023
Statut: ppublish

Résumé

The 16

Identifiants

DOI: 10.4155/bio-2023-0167 PMID: 37650500
pubmed: 37650500
doi: 10.4155/bio-2023-0167
doi:

Substances chimiques

Vaccines 0
Biomarkers 0
Oligonucleotides 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

955-1016

Subventions

Organisme : World Health Organization
ID : 001
Pays : International

Auteurs

Matt Szapacs (M)

Abbvie, Philadelphia, PA, USA.

Wenying Jian (W)

Janssen, Spring House, PA, USA.

Daniel Spellman (D)

Merck, West Point, PA, USA.

Jennifer Cunliffe (J)

Novartis, Cambridge, MA, USA.

Elizabeth Verburg (E)

Lilly, Indianapolis, IN, USA.

Surinder Kaur (S)

Genentech, South San Francisco, CA, USA.

John Kellie (J)

GlaxoSmithKline, Collegeville, PA, USA.

Wenkui Li (W)

Novartis, East Hanover, NJ, USA.

John Mehl (J)

GlaxoSmithKline, Collegeville, PA, USA.

Mark Qian (M)

Takeda, Cambridge, MA, USA.

Xiazi Qiu (X)

WRIB, Montreal, QC, Canada.

Federico Riccardi Sirtori (FR)

EMD Serono, Ivrea, TO, Italy.

Anton I Rosenbaum (AI)

AstraZeneca, South San Francisco, CA, USA.

Tim Sikorski (T)

GlaxoSmithKline, Collegeville, PA, USA.

Sekhar Surapaneni (S)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Jian Wang (J)

Crinetics, San Diego, CA, USA.

Amanda Wilson (A)

AstraZeneca, Cambridge, UK.

Jinhui Zhang (J)

US FDA, Silver Spring, MD, USA.

Yongjun Xue (Y)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Noah Post (N)

Ionis, Carlsbad, CA, USA.

Yue Huang (Y)

AstraZeneca, South San Francisco, CA, USA.

Dina Goykhman (D)

Merck, West Point, PA, USA.

Long Yuan (L)

Biogen, Cambridge, MA, USA.

Kasie Fang (K)

GlaxoSmithKline, Collegeville, PA, USA.

Ellen Casavant (E)

Genentech, South San Francisco, CA, USA.

Linzhi Chen (L)

Boehringer Ingelheim, Ridgefield, CT, USA.

Yunlin Fu (Y)

Novartis, East Hanover, NJ, USA.

Ming Huang (M)

Regeneron, Tarrytown, NY, USA.

Allena Ji (A)

Chiesi, Boston, MA, USA.

Jay Johnson (J)

Pfizer, Andover, MA, USA.

Michael Lassman (M)

Merck, West Point, PA, USA.

Jing Li (J)

Alnylam, Cambridge, MA, USA.

Ola Saad (O)

Genentech, South San Francisco, CA, USA.

Hetal Sarvaiya (H)

Abbvie, San Mateo, CA, USA.

Lin Tao (L)

Sanofi, Framingham, MA, USA.

Yuting Wang (Y)

WRIB, Montreal, QC, Canada.

Naiyu Zheng (N)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Arindam Dasgupta (A)

US FDA, Silver Spring, MD, USA.

Mohsen Rajabi Abhari (MR)

US FDA, Silver Spring, MD, USA.

Akiko Ishii-Watabe (A)

Japan MHLW, Tokyo, Japan.

Yoshiro Saito (Y)

Japan MHLW, Tokyo, Japan.

Dulcyane Neiva Mendes Fernandes (DN)

Brazil ANVISA, Brasilia, Brazil.

Joseph Bower (J)

Precision for Medicine, Chantilly, VA, USA.

Chris Burns (C)

UK MHRA, London, UK.

Kevin Carleton (K)

Janssen, Spring House, PA, USA.

Seongeun Julia Cho (SJ)

US FDA, Silver Spring, MD, USA.

Xiulian Du (X)

US FDA, Silver Spring, MD, USA.

Marianne Fjording (M)

EWG ICH M10, Copenhagen, Denmark.

Fabio Garofolo (F)

BRI Frontage, Vancouver, BC, Canada.

Sumit Kar (S)

WRIB, Montreal, QC, Canada.

Olga Kavetska (O)

Pfizer, Groton, CT, USA.

Elham Kossary (E)

WHO, Geneva, Switzerland.

Yang Lu (Y)

US FDA, Silver Spring, MD, USA.

Andrew Mayer (A)

GlaxoSmithKline, Collegeville, PA, USA.

Nisha Palackal (N)

Regeneron, Tarrytown, NY, USA.

Danielle Salha (D)

Altasciences, Laval, QC, Canada.

Eric Thomas (E)

Labcorp, Indianapolis, IN, USA.

Tom Verhaeghe (T)

Janssen, Beerse, Belgium.

Stephen Vinter (S)

UK MHRA, London, UK.

Katty Wan (K)

Pfizer, San Diego, CA, USA.

Yow-Ming Wang (YM)

US FDA, Silver Spring, MD, USA.

Kathi Williams (K)

Genentech, South San Francisco, CA, USA.

Eric Woolf (E)

Merck, West Point, PA, USA.

Li Yang (L)

US FDA, Silver Spring, MD, USA.

Eric Yang (E)

GlaxoSmithKline, Collegeville, PA, USA.

Abbas Bandukwala (A)

US FDA, Silver Spring, MD, USA.

Shirley Hopper (S)

UK MHRA, London, UK.

Kevin Maher (K)

US FDA, Silver Spring, MD, USA.

Joshua Xu (J)

US FDA, Jefferson, AR, USA.

Eric Brodsky (E)

US FDA, Silver Spring, MD, USA.

Isabelle Cludts (I)

UK MHRA, London, UK.

Chad Irwin (C)

Health Canada, Ottawa, ON, Canada.

Julie Joseph (J)

Health Canada, Ottawa, ON, Canada.

Susan Kirshner (S)

US FDA, Silver Spring, MD, USA.

Mohanraj Manangeeswaran (M)

US FDA, Silver Spring, MD, USA.

Kimberly Maxfield (K)

US FDA, Silver Spring, MD, USA.

Joao Pedras-Vasconcelos (J)

US FDA, Silver Spring, MD, USA.

Therese Solstad (T)

Norway NoMA, Oslo, Norway.

Seth Thacker (S)

US FDA, Silver Spring, MD, USA.

Omar Tounekti (O)

Health Canada, Ottawa, ON, Canada.

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Meenu Wadhwa (M)

UK MHRA, London, UK.

Leslie Wagner (L)

US FDA, Silver Spring, MD, USA.

Takenori Yamamoto (T)

Japan MHLW, Tokyo, Japan.

Lucia Zhang (L)

Health Canada, Ottawa, ON, Canada.

Lin Zhou (L)

US FDA, Silver Spring, MD, USA.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Chromatographie › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Facteurs biologiques › Marqueurs biologiques › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Thérapeutique › Biothérapie › Thérapie cellulaire et tissulaire › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Spectrométrie de masse › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Acides nucléiques, nucléotides et nucléosides › Nucléotides › Polynucléotides › Oligonucléotides › 2022 White Paper on Recent Issues in...
questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › 2022 White Paper on Recent Issues in...