Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials-Reference-Cited by-同舟云学术

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

Published:2014-10 Issue:1 Volume:70 Page:413-429
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Sewell Fiona,Chapman Kathryn,Baldrick Paul,Brewster David,Broadmeadow Alan,Brown Paul,Burns-Naas Leigh Ann,Clarke Janet,Constan Alex,Couch Jessica,Czupalla Oliver,Danks Andy,DeGeorge Joseph,de Haan Lolke,Hettinger Klaudia,Hill Marilyn,Festag Matthias,Jacobs Abby,Jacobson-Kram David,Kopytek Stephan,Lorenz Helga,Moesgaard Sophia Gry,Moore Emma,Pasanen Markku,Perry Rick,Ragan Ian,Robinson Sally,Schmitt Petra M.,Short Brian,Lima Beatriz Silva,Smith Diane,Sparrow Sue,van Bekkum Yvette,Jones David

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference17 articles.

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3. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies;Brennan;MAbs,2010

4. Preclinical development of monoclonal antibodies: considerations for the use of non-human primates;Chapman;MAbs,2009

5. The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates;Chapman;Regul. Toxicol. Pharmacol.,2012

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