2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (

Biological Assay / standards Biomarkers / analysis Guidelines as Topic Humans Immunogenetic Phenomena Research Report United States United States Food and Drug Administration / legislation & jurisprudence

Journal

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

Informations de publication

Date de publication:
Dec 2019
Historique:
pubmed: 14 12 2019
medline: 28 4 2020
entrez: 14 12 2019
Statut: ppublish

Résumé

The 2019 13

Identifiants

DOI: 10.4155/bio-2019-0270 PMID: 31833782
pubmed: 31833782
doi: 10.4155/bio-2019-0270
doi:

Substances chimiques

Biomarkers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2099-2132

Auteurs

Brian Booth (B)

US FDA, Silver Spring, MD, USA.

Lauren Stevenson (L)

Biogen, Cambridge, MA, USA.

Renuka Pillutla (R)

Bristol-Myers Squibb, Princeton, NJ, USA.

Michael Buonarati (M)

Intertek, San Diego, CA, USA.

Chris Beaver (C)

Syneos Health, Princeton, NJ, USA.

Daniela Fraier (D)

F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Fabio Garofolo (F)

Angelini Pharma, Rome, Italy.

Sam Haidar (S)

US FDA, Silver Spring, MD, USA.

Rafiq Islam (R)

Celerion, Lincoln, NE, USA.

Christopher James (C)

Amgen Research, Thousand Oaks, CA, USA.

John Kadavil (J)

US FDA, Silver Spring, MD, USA.

Olga Kavetska (O)

Pfizer, Groton, CT, USA.

Fumin Li (F)

PPD, Middleton, WI, USA.

Christina Satterwhite (C)

Charles River, Reno, NV, USA.

Natasha Savoie (N)

CFABS, Montreal, QC, Canada.

Sriram Subramaniam (S)

US FDA, Silver Spring, MD, USA.

Nilufer Tampal (N)

US FDA, Silver Spring, MD, USA.

Theingi Thway (T)

US FDA, Silver Spring, MD, USA.

Eric Woolf (E)

Merck Research Labs, West Point, PA, USA.

Olivier Le Blaye (OL)

France ANSM, Saint Denis, France.

Matthew Andisik (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Chad Briscoe (C)

PRA Health Sciences, Lenexa, KS, USA.

Stephanie Cape (S)

Covance, Madison, WI, USA.

Arindam Dasgupta (A)

US FDA, Silver Spring, MD, USA.

Sally Fischer (S)

Genentech, South San Francisco, CA, USA.

Sam Haidar (S)

US FDA, Silver Spring, MD, USA.

Roger Hayes (R)

ICON, Whitesboro, NY, USA.

John Kamerud (J)

Pfizer, Andover, MA, USA.

Gustavo Mendes Lima Santos (GM)

Brazil ANVISA, Brasilia, Brazil.

Corey Nehls (C)

PPD, Richmond, VA, USA.

Catherine Soo (C)

Health Canada, Ottawa, ON, Canada.

Stephen Vinter (S)

UK MHRA, London, UK.

Emma Whale (E)

UK MHRA, London, UK.

Keyang Xu (K)

Genentech, South San Francisco, CA, USA.

Seongeun Julia Cho (SJ)

US FDA, Silver Spring, MD, USA.

Anna Edmison (A)

Health Canada, Ottawa, ON, Canada.

Sean Kassim (S)

US FDA, Silver Spring, MD, USA.

Thais Correa Rocha (TC)

Brazil ANVISA, Brasilia, Brazil.

Jan Welink (J)

EMA, London, UK.

Shashi Amur (S)

US FDA, Silver Spring, MD, USA.

Abbas Bandukwala (A)

US FDA, Silver Spring, MD, USA.

Elana Cherry (E)

Health Canada, Ottawa, ON, Canada.

Shirley Hopper (S)

UK MHRA-NIBSC, London, UK.

Akiko Ishii-Watabe (A)

Japan MHLW-NIHS, Tokyo, Japan.

Susan Kirshner (S)

US FDA, Silver Spring, MD, USA.

Kevin Maher (K)

US FDA, Silver Spring, MD, USA.

Joao Pedras-Vasconcelos (J)

US FDA, Silver Spring, MD, USA.

Yoshiro Saito (Y)

Japan MHLW-NIHS, Tokyo, Japan.

Therese Solstad Saunders (TS)

Norwegian Medicines Agency (NoMA), Oslo, Norway.

Venke Skibeli (V)

Norwegian Medicines Agency (NoMA), Oslo, Norway.

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Yow-Ming Wang (YM)

US FDA, Silver Spring, MD, USA.

Haoheng Yan (H)

US FDA, Silver Spring, MD, USA.

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Classifications MeSH

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questionsmedicales.fr › Phénomènes du système immunitaire › Phénomènes immunogénétiques › 2019 White Paper On Recent Issues in...
questionsmedicales.fr › Sciences de l'information › Langage › Arts du langage › Écriture › Rapport de recherche › 2019 White Paper On Recent Issues in...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › 2019 White Paper On Recent Issues in...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › 2019 White Paper On Recent Issues in...