Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice

Author:

Namdari Rostam,Jones Keith,Chuang Samuel S.,Van Cruchten StevenORCID,Dincer Zuhal,Downes Noel,Mikkelsen Lars Friis,Harding Joanna,Jäckel SvenORCID,Jacobsen BjörnORCID,Kinyamu-Akunda Jacqueline,Lortie Andréanne,Mhedhbi SofieneORCID,Mohr Susanne,Schmitt Michael W.,Prior HelenORCID

Funder

Roche

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference24 articles.

1. 2010/63/Eu, Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the Protection of Animals Used for Scientific Purposes.

2. Group housing of male CD1 mice: reflections from toxicity studies;Annas;Lab. Anim,2013

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

4. Nonclinical & clinical interface - extrapolation of nonclinical data to support Phase I clinical studies;Baldrick;Regul. Toxicol. Pharmacol.,2021

5. Current strategies in the non-clinical safety assessment of biologics: new targets, new molecules, new challenges;Brennan;Regul. Toxicol. Pharmacol.,2018

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