Toxicology and regulatory sciences bibliography and resources

Refinement of mammalian acute toxicity studies in testing of chemicals

Sewell F et al, (2024). New supporting data to guide the use of evident toxicity in acute oral toxicity studies (OECD TG 420).  Regulatory Toxicology and Pharmacology 146:105517. doi: 10.1016/j.yrtph.2023.105517

Sewell F et al, (2018). An evaluation of the fixed concentration procedure for assessment of acute inhalation toxicity. Regulatory Toxicology and Pharmacology 94: 22-32. doi: 10.1016/j.yrtph.2018.01.001

OECD (2017). Test no. 433: Acute Inhalation Toxicity: Fixed Concentration Procedure. OECD Publishing, Paris. doi: 10.1787/9789264284166-en

Sewell F et al, (2015). A global initiative to refine acute inhalation studies through the use of ‘evident toxicity’ as an endpoint: towards adoption of the fixed concentration procedure. Regulatory Toxicology and Pharmacology 73(3): 770-9. doi: 10.1016/j.yrtph.2015.10.018

Price C et al, (2011). A statistical evaluation of the effects of gender differences in assessment of acute inhalation toxicity. Human and Experimental Toxicology 30(3): 217-238. doi: 10.1177/0960327110370982

Stallard N et al, (2011). A new sighting study for the fixed concentration procedure to allow for gender differences. Human and Experimental Toxicology 30(3): 239-249. doi: 10.1177/0960327110370983

Applying the 3Rs in fish acute toxicity studies

Katsiadaki I et al, (2021). Dying for change: A roadmap to refine the fish acute toxicity test after 40 years of applying a lethal endpoint. Ecotoxicology and Environmental Safety 223:112585. doi: 10.1016/j.ecoenv.2021.112585

Burden N et al, (2020). Key opportunities to replace, reduce and refine regulatory fish acute toxicity tests. Environmental Toxicology and Chemistry doi: 10.1002/etc.4824

Burden N et al, (2016). The utility of QSARs in predicting acute fish toxicity of pesticide metabolites: A retrospective validation approach. Regulatory Toxicology and Pharmacology 80:241-6. doi: 10.1016/j.yrtph.2016.05.032

Creton S et al, (2014). Application of the threshold approach for acute fish toxicity testing to plant protection products: a proposed framework. Chemosphere 96: 195-200. doi: 10.1016/j.chemosphere.2013.10.015

Redundancy in the acute toxicity testing of chemicals

Moore NP et al, (2013). Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Regulatory Toxicology and Pharmacology 66(1): 30-7. doi: 10.1016/j.yrtph.2013.02.005

Creton S et al, (2010). Acute toxicity testing of chemicals – Opportunities to avoid redundant testing and use alternative approaches. Critical Reviews in Toxicology 40: 50-83. doi: 10.3109/10408440903401511

Seidle T et al, (2010). Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicological Sciences 116(2): 382-396. doi: 10.1093/toxsci/kfq143

Single dose acute toxicity studies for new medicines

Chapman K et al, (2010). The value of acute toxicity studies to support the clinical management of overdose and poisoning: a cross-discipline consensus. Regulatory Toxicology and Pharmacology 58(3): 354-359. doi: 10.1016/j.yrtph.2010.07.003

Robinson S and Chapman K (2009). Are acute toxicity studies required to support overdose for new medicines? Regulatory Toxicology and Pharmacology 55(1): 110. doi: 10.1016/j.yrtph.2009.06.012

Robinson S et al, (2008). A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regulatory Toxicology and Pharmacology 50(3): 345-352. doi: 10.1016/j.yrtph.2007.11.009

Chapman K and Robinson S (2007). Workshop Report: Challenging the regulatory requirement for acute toxicity studies in the development of new medicines. NC3Rs, London. 

Applying the one concentration approach in fish bioaccumulation studies

Burden N et al, (2017). Reducing the number of fish in regulatory bioconcentration testing: Identifying and overcoming the barriers to using the 1-concentration approach. Integrated Environmental Assessment and Management 13(1): 212-4. doi: 10.1002/ieam.1851

Burden N et al, (2014). Reducing the number of fish in bioconcentration studies with general chemicals by reducing the number of test concentrations. Regulatory Toxicology and Pharmacology 70(2): 442-5. doi: 10.1016/j.yrtph.2014.08.008

Creton S et al, (2013). Reducing the number of fish in bioconcentration studies for plant protection products by reducing the number of test concentrations. Chemosphere 90(3): 1300-4. doi: 10.1016/j.chemosphere.2012.09.029

Applying the 3Rs in non-mammalian endocrine disruptor assessment

Burden N et al, (2023). An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice. Regulatory Toxicology and Pharmacology 145: 105501. doi: 10.1016/j.yrtph.2023.105501

Brown RJ et al, (2023). Are changes in vitellogenin concentrations in fish reliable indicators of chemical-induced endocrine activity? Ecotoxicology and Environmental Safety 266: 115563. doi: 10.1016/j.ecoenv.2023.115563

Mitchell C et al, (2023). New Approach Methodologies for the Endocrine Activity Toolbox: Environmental Assessment for Fish and Amphibians. Environmental Toxicology and Chemistry doi: 10.1002/etc.5584

Ortego L et al, (2021). The Extended Amphibian Metamorphosis Assay (EAMA): A thyroid-specific and less animal-intensive alternative to the Larval Amphibian Growth and Development Assay (LAGDA, OECD TG 241). Environmental Toxicology and Chemistry 40(8):2135-2144.  doi: 10.1002/etc.5078

Burden N et al, (2021). Investigating endocrine disrupting properties of chemicals in fish and amphibians: opportunities to apply the 3Rs. Integrated Environmental Assessment and Management doi: 10.1002/ieam.4497

Wheeler JR et al, (2021). Hormone data collection in support of endocrine disruption (ED) assessment for aquatic vertebrates: Pragmatic and animal welfare considerations. Environ International 146:106287. doi: 10.1016/j.envint.2020.106287

Lagadic L et al, (2019). Recommendations for reducing the use of fish and amphibians in endocrine-disruption testing of biocides and plant protection products in Europe. Integrated Environmental Assessment and Management 15: 659-662. doi: 10.1002/ieam.4156

Assessing the need for chronic fish studies on formulated pesticides

Creton S et al, (2010). Challenging the requirement for chronic fish toxicity studies on formulated plant protection products. Toxicology Letters 199(2): 111-4. doi: 10.1016/j.toxlet.2010.08.019

Reducing repetition of regulatory vertebrate ecotoxicology studies

Burden N et al, (2017). Reducing repetition of regulatory vertebrate ecotoxicology studies. Integrated Environmental Assessment and Management 13(5) 955-7. doi: 10.1002/ieam.1934

Reviews / Other / Miscellaneous

Burden N et al, (2016). Advancing the 3Rs in regulatory ecotoxicology: A pragmatic cross-sector approach. Integrated Environmental Assessment and Management 12(3): 417-421. doi: 10.1002/ieam.1703

Lillicrap A et al, (2016). Alternative approaches to vertebrate ecotoxicity tests in the 21st century: A review of developments over the last 2 decades and current status. Environmental Toxicology and Chemistry 35(11): 2637-2646. doi: 10.1002/etc.3603

Hutchinson TH et al, (2015). Promoting the 3Rs to enhance the OECD fish toxicity testing framework. Regulatory Toxicology and Pharmacology 76: 231-3. doi: 10.1016/j.yrtph.2016.02.006

Burden N and Hutchinson TH (2015). Benefits of the ARRIVE Guidelines for improving scientific reporting in ecotoxicology – An academic perspective. Environmental Toxicology and Chemistry 34(11): 2446-8. doi: 10.1002/etc.3111

Applying exposure science to increase the utility of non-animal data in efficacy and safety testing

Sewell F et al, (2017). The current status of exposure-driven approaches for chemical safety assessment: A cross-sector perspective. Toxicology 389: 109-117. doi: 10.1016/j.tox.2017.07.018

NC3Rs/Unilever (2017). Workshop report: Applying exposure science to increase the utility of non-animal data in efficacy and safety testing. NC3Rs/Unilever, London.  

Rowbotham AL and Gibson RM (2011). Exposure-driven risk assessment: Applying exposure-based waiving of toxicity tests under REACH. Food and Chemical Toxicology 49(8): 1661-1673. doi: 10.1016/j.fct.2011.03.050

Pharmacokinetics in candidate selection

Beaumont K et al, (2011). Towards an integrated human clearance prediction strategy that minimizes animal use. Journal of Pharmaceutical Sciences 100:1167–1783. doi: 10.1002/jps.22635

Lave T et al, (2009). Human clearance prediction: shifting the paradigm. Expert Opinion on Drug Metabolism & Toxicology 5(9): 1039-1048. doi: 10.1517/17425250903099649

Refining MTD studies

Sewell et al, (2022). Recommendations on dose level selection for repeat dose toxicity studies. Archives of Toxicology 96: 1921–1934. doi: 10.1007/s00204-022-03293-3

ECETOC Guidance on Dose Selection (2020). Technical report 138, Brussels, March 2021. ISSN-2079-1526-138.

Chapman K et al, (2013). A global pharmaceutical company initiative: An evidence-based approach to define the upper limit of body weight loss in short term toxicity studies. Regulatory Toxicology and Pharmacology 67(1): 27-38. doi: 10.1016/j.yrtph.2013.04.003

Robinson S et al, (2009). Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals. NC3Rs/LASA, London.

Toxicokinetics in the chemicals industry

Tan YM et al, (2021). Opportunities and challenges related to saturation of toxicokinetic processes: implications for risk assessment. Regulatory Toxicology and Pharmacology 127: 105070. doi: 10.1016/j.yrtph.2021.105070

Sewell F et al, (2020). Use of the kinetically-derived maximum dose: Opportunities for delivering 3Rs benefits. Regulatory Toxicology and Pharmacology. 116:104734. doi: 10.1016/j.yrtph.2020.104734

Creton S et al, (2012). Use of toxicokinetics to support chemical evaluation: Informing high dose selection and study interpretation. Regulatory Toxicology and Pharmacology 62(2): 241-7. doi: 10.1016/j.yrtph.2011.12.005

Creton S et al, (2009). Application of toxicokinetics to improve chemical risk assessment: Implications for the use of animals. Regulatory Toxicology and Pharmacology 55: 291-9. doi: 10.1016/j.yrtph.2009.08.001

Grimm H et al, (2023). Advancing the 3Rs: innovation, implementation, ethics and society. Frontiers in Veterinary Science 10:1185706. doi: 10.3389/fvets.2023.1185706

Bishop PL et al, (2023). Challenges and opportunities for overcoming dog use in agrochemical evaluation and registration. ALTEX. doi: 10.14573/altex.2302151

Burden N et al, (2015). Pioneering better science through the 3Rs: An introduction to the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs). Journal of the American Association for Laboratory Animal Science 54(2): 198-208. 

Holmes AM et al, (2010). Working in partnership to advance the 3Rs in toxicity testing. Toxicology 267(1-3): 14-9. doi: 10.1016/j.tox.2009.11.006

Application of non-animal approaches for decision making in chemical safety assessment

Langan L et al, (2023). Big Question to Developing Solutions: A Decade of Progress in the Development of Aquatic New Approach Methodologies from 2012 to 2022. Environmental Toxicology and Chemistry. doi: 10.1002/etc.5578

Wolf D et al, (2022). Transforming the Evaluation of Agrochemicals. Pest Management Science. doi: 10.1002/ps.7148

Sewell F et al, (2021). Rethinking Agrochemical Safety Assessment: A Perspective. Regulatory Toxicology and Pharmacology 127:105068. doi: 10.1016/j.yrtph.2021.105068

LaLone C et al, (2021). International consortium to advance cross species extrapolation of the effects of chemicals in regulatory toxicology. Environmental Toxicology and Chemistry. 126: e105029. doi: 10.1002/etc.5214

Prior H et al, (2019). Reflections on the progress towards non-animal methods for acute toxicity testing of chemicals. Regulatory Toxicology and Pharmacology 102 30-3. doi: 10.1016/j.yrtph.2018.12.008

Hoffmann S et al, (2018). Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database. Critical Reviews in Toxicology 48: 344-358. doi: 10.1080/10408444.2018.1429385

Kleinstreuer NC et al, (2018). Non-animal methods to predict skin sensitization (II): an assessment of defined approaches. Critical Reviews in Toxicology 48: 359-374. doi: 10.1080/10408444.2018.1429386

van Vliet E et al, (2018). State-of-the-art and new options to assess T cell activation by skin sensitizers: Cosmetics Europe Workshop. ALTEX 35: 179-192. doi: 10.14573/altex.1709011

Sewell F et al, (2017). Steps towards the international regulatory acceptance of non-animal methodology in safety assessment. Regulatory Toxicology and Pharmacology 89: 50-6. doi: 10.1016/j.yrtph.2017.07.001

Burden N et al, (2015). Testing chemical safety: What is needed to ensure the widespread application of non-animal approaches? PLoS Biology 13(5): e1002156. doi: 10.1371/journal.pbio.1002156

Burden N et al, (2015). Aligning the 3Rs with new paradigms in the safety assessment of chemicals. Toxicology 330: 62-6. doi: 10.1016/j.tox.2015.01.014

Adler S et al, (2011). Alternative (non-animal) methods for cosmetics testing: current status and future prospects – 2010. Archives of Toxicology 85(5): 367-485. doi: 10.1007/s00204-011-0693-2

In vitro approaches for carcinogenicity testing

Luijten M et al, (2020). A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals. Regulatory Toxicology and Pharmacology. 118: 104789. doi: 10.1016/j.yrtph.2020.104789

Creton S et al, (2012). Cell transformation assays for prediction of carcinogenic potential: state of the science and future research needs. Mutagenesis 27(1): 93-101. doi: 10.1093/mutage/ger053

Modelling and computational approaches

Gellatly N and Sewell F (2019). Regulatory acceptance of in silico approaches for the safety assessment of cosmetic-related substances. Computational Toxicology 11: 82-9.  doi: 10.1016/j.comtox.2019.03.003

Hasselgren C et al, (2019). Genetic toxicology in silico protocol. Regulatory Toxicology and Pharmacology, 107: 104403. doi: 10.1016/j.yrtph.2019.104403

Myatt GJ et al, (2018). In silico toxicology protocols. Regulatory Toxicology and Pharmacology 96: 1-17. doi: 10.1016/j.yrtph.2018.04.014

Pathways based approaches

Rivetti C et al, (2020). Vision of a near future: Bridging the human health-environment divide. Toward an integrated strategy to understand mechanisms across species for chemical safety assessment. Toxicology In Vitro 62: 104692. doi: 10.1016/j.tiv.2019.104692

Sewell F et al, (2018). The future trajectory of adverse outcome pathways: a commentary. Archives of Toxicology 92(4): 1657-1661. doi: 10.1007/s00204-018-2183-2

Burden N et al, (2015). Adverse Outcome Pathways can drive non-animal approaches for safety assessment. Journal of Applied Toxicology 35(9): 971-975. doi: 10.1002/jat.3165

Reducing animal use in the safety assessment of nanomaterials

Burden N et al,(2021). Opportunities and Challenges for Integrating New In Vitro Methodologies in Hazard Testing and Risk Assessment. Small. (15):e2006298. doi: 10.1002/smll.202006298

Burden N et al, (2017). The 3Rs as a framework to support a 21st century approach for nanosafety assessment. Nano Today 12: 10-13. doi: 10.1016/j.nantod.2016.06.007

Burden N et al, (2017). Aligning nanotoxicology with the 3Rs: What is needed to realise the short, medium and long-term opportunities? Regulatory Toxicology and Pharmacology 91: 257-266. doi: 10.1016/j.yrtph.2017.10.021

Use of human or engineered tissues in safety assessment

Jackson SJ et al, (2018). The use of human tissue in safety assessment. Journal of Pharmacological and Toxicological Methods 93:29-34. doi: 10.1016/j.vascn.2018.05.003

Holmes A et al, (2017). Rising to the challenge: applying biofabrication approaches for better drug and chemical product development. Biofabrication 9: 033001. doi: 10.1088/1758-5090/aa7bbd

Holmes A et al, (2015). Assessing drug safety in human tissues — what are the barriers? Nature Reviews Drug Discovery 14: 585–7 (2015). doi: 10.1038/nrd4662

Westmoreland C and Holmes A (2009). Assuring consumer safety without animals: Applications for tissue engineering. Organogenesis 5: 67-72. doi: 10.4161/org.5.2.9128

Holmes A et al, (2009). Engineering tissue alternatives to animals: applying tissue engineering to basic research and safety testing. Regenerative Medicine 4: 572-92.  doi.org/10.2217/rme.09.26

Abuse potential studies

O'Connor E et al, (2011). The predictive validity of the rat self-administration model for abuse liability. Neuroscience & Biobehavioral Reviews 35(3): 912-938. doi: 10.1016/j.neubiorev.2010.10.012

Assessing the predictive value of safety pharmacology studies

Jackson SJ et al, (2019). Neurofunctional test batteries in safety pharmacology – Current and emerging considerations for the drug development process. Journal of Pharmacological and Toxicological Methods 100: 106602 doi: 10.1016/j.vascn.2019.106602

Redfern WS et al, (2019). The functional observational battery and modified Irwin test as global neurobehavioral assessments in the rat: Pharmacological validation data and a comparison of methods. Journal of Pharmacological and Toxicological Methods 98: 106591 doi: 10.1016/j.vascn.2019.106591

Mead AN et al, (2016). Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials. Regulatory Toxicology and Pharmacology. 80: 348-357. doi: 10.1016/j.yrtph.2016.05.002

Social housing during rodent and non-rodent telemetry recordings

Prior H and Holbrook M (2021). Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents. Journal of Pharmacological and Toxicological Methods 108: 106959. doi: 10.1016/j.vascn.2021.106959

Skinner M et al, (2019). Social-housing and use of double-decker cages in rat telemetry studies. Journal of Pharmacological and Toxicological Methods 96: 87-94. doi: 10.1016/j.vascn.2019.02.005

Prior H et al, (2016). Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies. Journal of Pharmacological and Toxicological Methods 81: 75-87. doi: 10.1016/j.vascn.2016.03.004

Reviews / Other

Guns PJ et al, (2020).  INSPIRE: A European training network to foster research and training in cardiovascular safety pharmacology.  Journal of Pharmacological and Toxicological Methods 105: 106889. doi: 10.1016/j.vascn.2020.106889

Saleem U et al, (2020). Blinded, Multicenter Evaluation of Drug-induced Changes in Contractility Using Human-induced Pluripotent Stem Cell-derived Cardiomyocytes. Toxicological Sciences 176: 103–123. doi: 10.1093/toxsci/kfaa058

Tse K et al, (2018). Pharmacological validation of individual animal locomotion, temperature and behavioural analysis in group-housed rats using a novel automated home cage analysis system: A comparison with the modified Irwin test. Journal of Pharmacological and Toxicological Methods 94: 1-13. https://doi.org/10.1016/j.vascn.2018.03.008 

Grant C et al, (2017). Provision of food and water in rodent whole body plethysmography safety pharmacology respiratory studies - Impact on animal welfare and data quality. Journal of Pharmacological and Toxicological Methods. 88: 79-84. doi: 10.1016/j.vascn.2017.07.004

Redfern W et al, (2017). Automated recording of home cage activity and temperature of individual rats housed in social groups: The Rodent Big Brother. PLoS One 12(9): e0181068. doi:10.1371/journal.pone.0181068

Maximising the success of bile duct cannulation (BDC) studies

Burden N et al, (2017). Maximizing the success of bile duct cannulation studies in rats: recommendations for best practice. Laboratory Animals 51(5): 457-464. doi: 10.1177/0023677217698001.

Microsampling

Coleman D et al, (2017). Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective.  Bioanalysis 9(10): 787-798. doi: 10.4155/bio-2017-0032

Chapman K et al, (2014). Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discovery Today 19(5): 528-532. doi: 10.1016/j.drudis.2014.01.002.

Chapman K et al, (2014). Reducing pre-clinical blood volumes for toxicokinetics: toxicologists, pathologists and bioanalysts unite. Bioanalysis 6(22): 2965-8. doi: 10.4155/bio.14.204.

Reducing animal use in monoclonal antibody (mAb) development

Chien H et al, (2023). Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach. Regulatory Toxicology and Pharmacology 138:105329. doi:10.1016/j.yrtph.2022.105329

Sewell F et al, (2017). Challenges and opportunities for the future use of monoclonal antibody development: improving safety assessment and reducing animal use. mAbs 9(5): 742-755. doi: 10.1080/19420862.2017.1324376.

Chapman K et al, (2016). Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges. mAbs 8(3): 427-435. doi: 10.1080/19420862.2016.1145331.

Chapman KL et al, (2012). The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates. Regulatory Toxicology and Pharmacology 62(2): 347-354. doi: 10.1016/j.yrtph.2011.10.016.

Buckley LA et al, (2011). Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals. International Journal of Toxicology 30(5): 583-590. doi: 10.1177/1091581811415875.

Chapman KL et al, (2010). The future of non-human primate use in mAb development. Drug Discovery Today 15(5-6): 235-242. doi: 10.1016/j.drudis.2010.01.002.

Chapman K et al, (2009). Preclinical development of monoclonal antibodies: considerations for the use of non-human primates. mAbs 1(5): 505-516. doi: 10.4161/mabs.1.5.9676.

Chapman K et al, (2007). Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nature Reviews Drug Discovery 6(2): 120-6. doi: 10.1038/nrd2242.

NC3Rs/ABPI (2006). Workshop report: Opportunities for reducing the use of non-human primates in the development of monoclonal antibodies.  NC3Rs/ABPI, London.

Reducing the use of recovery animals

Prior H et al, (2023). The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain. Regulatory Toxicology and Pharmacology 138:105339. doi: 10.1016/j.yrtph.2023.105339

Sewell F et al, (2014). 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. Regulatory Toxicology and Pharmacology 70(1): 413-429. doi: 10.1016/j.yrtph.2014.07.018.

Review of the use of two species

Prior H et al, (2022). Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species. International Journal of Toxicology 41(3), 171–181. doi: 10.1177/10915818221081439

Namdari R et al, (2021). Species selection for nonclinical safety assessment of drug candidates: Examples of current industry practice. Regulatory Toxicology and Pharmacology 126: 105029. doi: 10.1016/j.yrtph.2021.105029.

Prior H et al, (2020). Justification for species selection for pharmaceutical toxicity studies. Toxicology Research 9: 758-770. doi: 10.1093/toxres/tfaa081.

Prior H et al, (2020). Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation. Regulatory Toxicology and Pharmacology 113: 104624. doi: 10.1016/j.yrtph.2020.104624.

Prior H et al, (2019). Integration of consortia recommendations for justification of animal use within current and future drug development paradigms. International Journal of Toxicology 38(4), 319–325. doi: 10.1177/1091581819852922.

Prior H et al, (2018). Reviewing the utility of two species in general toxicology related to drug development. International Journal of Toxicology 37(2): 121-4. doi: 10.1177/1091581818760564.

Reviews / Other

Prior H et al, (2021). Refining Procedures within Regulatory Toxicology Studies: Improving Animal Welfare and Data. Animals 11: 3057. doi: 10.3390/ani11113057.

Sewell F et al, (2021). Preclinical screening for antidepressant activity – shifting focus away from the Forced Swim Test to the use of translational biomarkers. Regulatory Toxicology and Pharmacology 125:105002. doi: 10.1016/j.yrtph.2021.105002.

Lilley E et al, (2021). Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals. Biologicals 74: 24-27. doi: 10.1016/j.biologicals.2021.10.002

Clements JM et al, (2020). Predicting the Safety of Medicines in Pregnancy: a Workshop Report. Reproductive Toxicology, S0890-6238(20)30024-1. doi: 10.1016/j.reprotox.2020.02.011.

NC3Rs (2019). Workshop report: Applying the 3Rs in pharma: Improving delivery of innovative medicines to patients. NC3Rs, London.

Prior H et al, (2017). Overview of 3Rs opportunities in drug discovery and development using non-human primates. Drug Discovery Today: Disease Models 23, 11-16. doi: 10.1016/j.ddmod.2017.11.005.

Sewell F et al, (2016). Opportunities to apply the 3Rs in safety assessment programs. Institute for Laboratory Animal Research Journal 57(2): 234-245. doi: 10.1093/ilar/ilw024.

Chapman KL et al, (2013). Pharmaceutical toxicology: designing studies to reduce animal use, while maximizing human translation. Regulatory Toxicology and Pharmacology 66(1): 88-103. doi: 10.1016/j.yrtph.2013.03.001.

Sparrow SS et al, (2011). Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: A cross company review. Regulatory Toxicology and Pharmacology 61(2): 222-9. doi: 10.1016/j.yrtph.2011.08.001.