Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation

Author:

Prior Helen,Baldrick Paul,Beken Sonja,Booler Helen,Bower Nancy,Brooker Paul,Brown Paul,Burlinson Brian,Burns-Naas Leigh Ann,Casey Warren,Chapman Melissa,Clarke David,de Haan Lolke,Doehr Olaf,Downes Noel,Flaherty Meghan,Gellatly Nichola,Moesgaard Sophia Gry,Harris Jennifer,Holbrook Mark,Hui Julia,Jones David,Jones Keith,Kedar Hilla,Mahl Andreas,Manninen Alli,McGuire Aidan,Mortimer-Cassen Elisabeth,Peraza Marjorie,Pugsley Michael K.,Richard Jacques,Roberts Ruth,Roosen Wendy,Rothfuss Andreas,Schoenmakers Ankie,Sewell Fiona,Weaver Richard,Weir Lucinda,Wolfreys Alison,Kimber Ian

Funder

III

ICH

NC3Rs

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference39 articles.

1. Predicting human drug toxicity and safety via animal tests: can any one species predict drug toxicity in any other, and do monkeys help? Alternatives to laboratory animals;Bailey;ATLA,2015

2. Safety evaluation to support First-In-Man investigations II: toxicology studies;Baldrick;Regul. Toxicol. Pharmacol. : RTP (Regul. Toxicol. Pharmacol.),2008

3. Safety evaluation of biological drugs: what are toxicology studies in primates telling us?;Baldrick;Regul. Toxicol. Pharmacol. : RTP (Regul. Toxicol. Pharmacol.),2011

4. Getting a molecule into the clinic: nonclinical testing and starting dose considerations;Baldrick;Regul. Toxicol. Pharmacol. : RTP (Regul. Toxicol. Pharmacol.),2017

5. Strategies and challenges for the next generation of antibody-drug conjugates;Beck;Nat. Rev. Drug Discov.,2017

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