Letters to the Editor

Bailey J. , Thew M. & Balls M. (2013). An analysis of the use of dogs in predicting human toxicology and drug safety. ATLA 41, 335–350.

Anon. (2009). Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, Code M3(R2), finalised June 2008. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). See Federal Register 75 3471–3472, Docket No. FDA/2008/D/0470. Available at: http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html (Accessed 04.03.14).

Robinson S. , Delongeas J. , Donald E. , Dreher D. , Festag M. , Kervyn S. , Lampo A. , Nahas K. , Nogues V. , Ockert D. , Quinn K. , Old S. , Pickersgill N. , Somers K. , Stark C. , Stei P. , Waterson L. & Chapman K. (2008). A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regulatory Toxicology & Pharmacology 50, 345–352.

Horner S. , Ryan D. , Robinson S. , Callander R. , Stamp K. & Roberts R.A. (2013). Target organ toxicities in studies conducted to support first time in man dosing: An analysis across species and therapy areas. Regulatory Toxicology & Pharmacology 65, 334–343.

Baldrick P. (2008). Safety evaluation to support First-In-Man investigations II: Toxicology studies. Regulatory Toxicology & Pharmacology 51, 237–243.

Broadhead C.L. , Betton G. , Combes R. , Damment S. , Everett D. , Garner C. , Godsafe Z. , Healing G. , Heywood R. , Jennings M. , Lumley C. , Oliver G. , Smith D. , Straughan D. , Topham J. , Wallis R. , Wilson S. & Buckley P. (2000). Prospects for reducing and refining the use of dogs in the regulatory toxicity testing of pharmaceuticals. Human & Experimental Toxicology 19, 440–447.

Olson H. , Betton G. , Robinson D. , Thomas K. , Monro A. , Kolaja G. , Lilly P. , Sanders J. , Sipes G. , Bracken W. , Dorato M. , Van Deun K. , Smith P. , Berger B. & Heller A. (2000). Concordance of the toxicity of pharmaceuticals in humans and in animals. Regulatory Toxicology & Pharmacology 32, 56–67.

Tamaki C. , Nagayama T. , Hashiba M. , Fujiyoshi M. , Hizue M. , Kodaira H. , Nishida M. , Suzuki K. , Takashima Y. , Ogino Y. , Yasugi D. , Yoneta Y. , Hisada S. , Ohkura T. & Nakamura K. (2013). Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: Correlation analysis of 142 approved drugs in Japan. Journal of Toxicological Sciences 38, 581–598.

Greaves P. , Williams A. & Eve M. (2004). First dose of potential new medicines to humans: How animals help. Nature Reviews Drug Discovery 3, 226–236.

Innovative Medicines Initiative (Commenced 2010). eTox project. Available at: http://www.imi.europa.eu/content/etox (Accessed 28.02.14).

Vamathevan J.J. , Hall M.D. , Hasan S. , Woollard P.M. , Xu M. , Yang Y. , Li X. , Wang X. , Kenny S. , Brown J.R. , Huxley-Jones J. , Lyon J. , Haselden J. , Min J. & Sanseau P. (2013). Minipig and beagle animal model genomes aid species selection in pharmaceutical discovery and development. Toxicology & Applied Pharmacology 270, 149–157.