Analysis of carcinogenicity testing for regulatory purposes in the European Union

.............................................................................................................. 7

[1]  Mardas Daneshian,et al.  Animal use for science in Europe. , 2015, ALTEX.

[2]  D. Rall LABORATORY ANIMAL TESTS AND HUMAN CANCER* , 2000, Drug metabolism reviews.

[3]  V. Rogiers,et al.  Inter-laboratory study of human in vitro toxicogenomics-based tests as alternative methods for evaluating chemical carcinogenicity: a bioinformatics perspective , 2015, Archives of Toxicology.

[4]  Daniel Morton,et al.  An Analysis of Pharmaceutical Experience with Decades of Rat Carcinogenicity Testing , 2011, Toxicologic pathology.

[5]  Corvi Raffaella,et al.  EURL ECVAM strategy to avoid and reduce animal use in genotoxicity testing , 2013 .

[6]  J. Ferlay,et al.  Global estimates of cancer prevalence for 27 sites in the adult population in 2008 , 2013, International journal of cancer.

[7]  K. Olejniczak,et al.  Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995-2009). , 2011, Regulatory toxicology and pharmacology : RTP.

[8]  A. Jacobs,et al.  History of Chronic Toxicity and Animal Carcinogenicity Studies for Pharmaceuticals , 2013, Veterinary pathology.

[9]  Susanna Louhimies Directive 86/609/EEC on the Protection of Animals Used for Experimental and Other Scientific Purposes 1 , 2002, Alternatives to laboratory animals : ATLA.

[10]  J. Kleinjans,et al.  Moving Forward in Human Cancer Risk Assessment , 2010, Environmental health perspectives.

[11]  J. Contrera,et al.  Carcinogenicity testing and the evaluation of regulatory requirements for pharmaceuticals. , 1997, Regulatory toxicology and pharmacology : RTP.

[12]  Jonathan Balcombe,et al.  Animal Carcinogenicity Studies: 1. Poor Human Predictivity , 2006, Alternatives to laboratory animals : ATLA.

[13]  Jonathan Balcombe,et al.  Animal Carcinogenicity Studies: 2. Obstacles to Extrapolation of Data to Humans , 2006, Alternatives to laboratory animals : ATLA.

[14]  Jonathan Balcombe,et al.  Animal Carcinogenicity Studies: 3. Alternatives to the Bioassay , 2006, Alternatives to laboratory animals : ATLA.

[15]  T. Knudsen,et al.  A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing. , 2012, ALTEX.

[16]  Rick Clayton,et al.  Advancing the 3Rs in regulatory toxicology - Carcinogenicity testing: Scope for harmonisation and advancing the 3Rs in regulated sectors of the European Union. , 2014, Regulatory toxicology and pharmacology : RTP.

[17]  C L Alden,et al.  A Critical Review of the Effectiveness of Rodent Pharmaceutical Carcinogenesis Testing in Predicting for Human Risk , 2011, Veterinary pathology.

[18]  J. Ferlay,et al.  Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. , 2013, European journal of cancer.

[19]  M. Stratton,et al.  The genome as a record of environmental exposure , 2015, Mutagenesis.

[20]  Saz Parkinson Zuleika Esther,et al.  Review and analysis of external quality assessment of breast cancer services in Europe: Supporting information for the development of a European Quality Assurance scheme for Breast Cancer Services , 2015 .

[21]  Paul L. Carmichael,et al.  Cell transformation assays for prediction of carcinogenic potential: state of the science and future research needs , 2011, Mutagenesis.

[22]  Alan R. Boobis,et al.  IPCS Framework for Analyzing the Relevance of a Noncancer Mode of Action for Humans , 2008, Critical reviews in toxicology.

[23]  A. Zell,et al.  Evaluation of Toxicogenomics Approaches for Assessing the Risk of Nongenotoxic Carcinogenicity in Rat Liver , 2014, PLoS ONE.

[24]  F. Madia,et al.  Current and Emerging In Vitro Methods for Genotoxicity and Carcinogenicity , 2014 .

[25]  C Helma,et al.  Data quality in predictive toxicology: reproducibility of rodent carcinogenicity experiments. , 2001, Environmental health perspectives.

[26]  C. Mathers,et al.  Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012 , 2015, International journal of cancer.

[27]  L Tomatis,et al.  Carcinogenesis bioassays: study duration and biological relevance. , 2001, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[28]  Valérie Zuang,et al.  Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010 , 2011, Archives of Toxicology.

[29]  Ivan Rusyn,et al.  Key Characteristics of Carcinogens as a Basis for Organizing Data on Mechanisms of Carcinogenesis , 2015, Environmental health perspectives.

[30]  B. Ames,et al.  What do animal cancer tests tell us about human cancer risk?: Overview of analyses of the carcinogenic potency database. , 1998, Drug metabolism reviews.

[31]  J. P. Van Oosterhout,et al.  The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe. , 1997, Regulatory toxicology and pharmacology : RTP.

[32]  Jacques Ferlay,et al.  The global burden of cancers attributable to infections in the year 2008: a review and synthetic analysis Web appendix section , 2012 .

[33]  Peter Kasper,et al.  Critical analysis of carcinogenicity study outcomes. Relationship with pharmacological properties , 2016, Critical reviews in toxicology.

[34]  M. J. Carmen,et al.  A proposal on cancer data quality checks: one common procedure for European cancer registries , 2014 .

[35]  C. Alden,et al.  Improving Carcinogenicity Assessment , 2013, Toxicologic pathology.

[36]  A. Monro Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents? , 1996, Experimental and toxicologic pathology : official journal of the Gesellschaft fur Toxikologische Pathologie.

[37]  Will all chemicals be carcinogenic to rodents when adequately evaluated? , 1993, Mutagenesis.

[38]  Hiroaki Kitano,et al.  Lessons from Toxicology: Developing a 21st-Century Paradigm for Medical Research , 2015, Environmental health perspectives.

[39]  Gbo,et al.  Prediction of carcinogenic potential of substances using repeated dose toxicity data , 2012 .

[40]  K. Woodward,et al.  Assessment of user safety, exposure and risk to veterinary medicinal products in the European Union. , 2008, Regulatory toxicology and pharmacology : RTP.

[41]  C. Mathers,et al.  GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer , 2013 .