Publications

Peer reviewed articles in scientific journals

2023

January 18, 2023

Turner J, Pound P, Owen C et al. Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment. ALTEX – Alternatives to animal experimentation. doi: 10.14573/altex.2212081. https://www.altex.org/index.php/altex/article/view/2592

2022

August 2022
Ram R, Gadaleta D, Allen T. The role of ‘big data’ and ‘in silico’ New Approach Methodologies (NAMs) in ending animal use – A commentary on progress. Computational Toxicology. https://www.sciencedirect.com/science/article/abs/pii/S2468111322000202?dgcid=author

August 19, 2022
Swaters D, van Veen A, van Meurs W, Turner JE, Ritskes-Hoitinga M. A History of Regulatory Animal Testing: What Can We Learn? 50th Anniversary Article.  Alternatives to Laboratory Animals. https://journals.sagepub.com/doi/pdf/10.1177/02611929221118001

May 3, 2022
Ritskes-Hoitinga, M, Pound P. The role of systematic reviews in identifying the limitations of preclinical animal research, 2000 – 2022. Part 1. Journal Royal Society Medicine, 2022; 115(5): 186-192. https://doi.org/10.1177%2F01410768221093551

May 6, 2022
Ritskes-Hoitinga, M, Pound P. The role of systematic reviews in identifying the limitations of preclinical animal research, 2000 – 2022. Part 2. Journal Royal Society Medicine, 2022; 115(6): 231-235. https://doi.org/10.1177/01410768221100970

The text for both of these can be found in the following open access source:

Ritskes-Hoitinga M, Pound P (2022). The role of systematic reviews in identifying the limitations of preclinical animal research, 2000 – 2022. JLL Bulletin: Commentaries on the history of treatment evaluation
https://www.jameslindlibrary.org/articles/the-role-of-systematic-reviews-in-identifying-the-limitations-of-preclinical-animal-research-2000-2022/

2021

December 13, 2021
Menon JML, Ritskes-Hoitinga M, Pound P, van Oort E. The impact of conducting preclinical systematic reviews on researchers and their research: A mixed method case study. PLoS ONE 2021;16(12): e0260619. https://doi.org/10.1371/journal.pone.0260619



Hubert Dirven, Gunn E. Vist, Sricharan Bandhakavi, Jyotsna Mehta, Seneca E. Fitch, Pandora Pound, Rebecca Ram, Breanne Kincaid, Cathalijn H. C. Leenaars, Minjun Chen, Robert A. Wright & Katya Tsaioun.  Performance of preclinical models in predicting drug-induced liver injury in humans: a systematic review. Sci Rep 11, 6403 (2021). https://doi.org/10.1038/s41598-021-85708-2



Our research consultant Dr Pandora Pound recently guest edited a special issue of the journal ‘Animals’ entitled “Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?” The key question she posed is whether there is value in refining animal models for medical research, or whether these should be relinquished in favour of new, human-focused research approaches. The seven open access, scientific papers that attempt to address this question, including Dr Pound’s editorial, can be found below.

Bhumika Singh, Mohamed Essameldin Abdelgawad, Zulfiqur Ali, Jarrod Bailey, Elisa Budyn, Prospero Civita, Martin J D Clift, John T Connelly, Samuel Constant, Marius Hittinger, Helena Kandarova, Victoria Rosalind Kearns, Tony Kiuru, Tomasz Kostrzewski, Sebastian Kress, Victoria Marsh Durban, Claus-Michael Lehr, Hayley McMillan, Julia Katharina Metz, Vivian Monteban, Dania Movia, Catia Neto, Carla Owen, Lauri Paasonen, Kerri Anne Palmer, Geoffrey John Pilkington, Karen Pilkington, Adriele Prina-Mello, Clive Roper, Jonathan Sheard, Sheree Smith, Janette Ellen Turner, Ipsita Roy, Melissa Anne Tutty, Eirini Velliou, John Malcolm Wilkinson. Towards More Predictive, Physiological and Animal-free In Vitro Models: Advances in Cell and Tissue Culture 2020 Conference Proceedings https://doi.org/10.1177/02611929211025006

2020

Pound P, Ram R. Are researchers moving away from animal models as a result of poor clinical translation in the field of stroke? An analysis of opinion papers. BMJ Open Science. 2020;4:e100041. doi: 10.1136/bmjos-2019-100041
Open Access https://openscience.bmj.com/content/4/1/e100041


Pound P, Ritskes-Hoitinga M. Can prospective systematic reviews of animal studies improve clinical translation?. Journal Translational Medicine. 2020;18:15 doi:10.1186/s12967-019-02205-x
Open Access https://doi.org/10.1186/s12967-019-02205-x

2018

Baker EJ, Beck NA, Berg EL, Clayton-Jeter HD, Chandrasekera PC, Curley JL, Donzanti BA, Ewart LC, Gunther JM, Kenna JG, LeCluyse EL. Advancing nonclinical innovation and safety in pharmaceutical testing. Drug Discovery Today. 2018 Nov 20.
Open Access https://doi.org/10.1016/j.drudis.2018.11.011


Archibald A, Tsaioun K, Kenna JG, Pound P. Better science for safer medicines: the human imperative. Journal of the Royal Society of Medicine 2018;
Open Access http://doi.org/10.1177%2F0141076818812783


Pound P, Ritskes-Hoitinga M. Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail. Journal Translational Medicine 2018; 16:304. Open Access https://doi.org/10.1186/s12967-018-1678-1


Kenna JG, Taskar KS, Battista C, Bourdet DL, Brouwer KL, Brouwer KR, Dai D, Funk C, Hafey MJ, Lai Y, Maher J. Can BSEP Inhibition Testing In Drug Discovery And Development Reduce Liver Injury Risk?‐An International Transporter Consortium Perspective. Clinical Pharmacology & Therapeutics. 2018 Aug 23. Open Access https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1222 DOI: https://doi.org/10.1002/cpt.1222


Kenna JG, Uetrecht J. Do In Vitro Assays Predict Drug Candidate Idiosyncratic Drug-Induced Liver Injury Risk? Drug Metabolism and Disposition. 2018; DOI: https://doi.org/10.1124/dmd.118.082719
https://www.ncbi.nlm.nih.gov/pubmed/30021844


Archibald K. Animal research is an Ethical issue for humans as Well as for Animals. Journal of Animal Ethics. 2018 Apr 1;8(1):1-1. https://www.jstor.org/stable/10.5406/janimalethics.8.1.0001?refreqid=robotstxt-sitemaps:1f1ee917778948ed08858f4972018b4a&seq=1#page_scan_tab_contents

2017

Kenna JG. Human biology-based drug safety evaluation: scientific rationale, current status and future challenges. Expert Opinion on Drug Metabolism & Toxicology. 2017;13(5):567-74.
https://www.ncbi.nlm.nih.gov/pubmed/28150517


Kenna G. Integrating DILI hazards enables prediction, assessment, and management of human risk. Drug Metabolism and Pharmacokinetics. 2017;1(32):S3.


Kenna G. DILI: What is the problem? Drug Metabolism and Pharmacokinetics 2017; 32(1):S2. Doi:10.1016/j.dmpk.2016.10.013


Ram R. Launch of the Alliance for Human Relevant Science. Alternatives to laboratory animals: ATLA. 2017 Mar 1;45(1):49-53.
PDF: Ram 2017

2016

Atienzar FA, Blomme EA, Chen M, Hewitt P, Kenna JG, Labbe G, Moulin F, Pognan F, Roth AB, Suter-Dick L, Ukairo O. Key challenges and opportunities associated with the use of in vitro models to detect human DILI: integrated risk assessment and mitigation plans. BioMed Research International. 2016; http://dx.doi.org/10.1155/2016/9737920
https://www.ncbi.nlm.nih.gov/pubmed/27689095

2015

Archibald K, Drake T, Coleman R. Barriers to the uptake of human-based test methods, and how to overcome them. Alternatives to Laboratory Animals. 2015;43(5):301-8.
PDF: Archibald et al 2015

2014

Coleman RA. Human-based systems in drug and chemical safety testing–toward replacement, the ‘single R’. Alternatives to laboratory animals: ATLA. 2014;42(6):357-66.
PDF: Coleman 2014

2013

Clotworthy M, Archibald K. Advances in the development and use of human tissue-based techniques for drug toxicity testing. Expert Opinion on Drug Metabolism & Toxicology. 2013;9(9):1155-69.

2011

Clotworthy M. Proceedings of the human tissues conference, House of Lords, 20 October 2009: Introduction. Cell and tissue banking. 2011 Feb 1;12(1):1-2.
PDF: Clotworthy 2011


Coleman RA. Efficacy and safety of new medicines: a human focus. Cell and tissue banking. 2011 Feb 1;12(1):3-5.
PDF: Coleman 2011

2009

Clotworthy M, Archibald K. Introduction to the proceedings of the Speed and Safety in Drug Discovery Symposium hosted by the Safer Medicines Trust. Preface. Alternatives to Laboratory Animals: ATLA. 2009:37;i-ii.


Clotworthy M, Coleman RA, Archibald K. The European Commission’s opinion backing use of non-human primates in research is flawed. Regulatory Affairs Journal Pharma. 2009
PDF: Clotworthy 2009

2007

Archibald K, Clotworthy M. Comment on ‘The ethics of animal research’ by Festing & Wilkinson. European Molecular Biology Organisation. 2007;8(9):794-6.
PDF: Archibald and Clotworthy 2007

2005

Bailey J. Non-human primates in medical research and drug development: a critical review. Biogenic Amines. 2005;19(4):235-56.
PDF: Bailey 2005


Bailey J, Knight A, Balcombe J. The future of teratology research is in vitro. Biogenic Amines. 2005;19(2):97-146.
PDF: Bailey et al 2005

Books

2023 Pandora Pound: Rat Trap: The capture of medicine by animal research – and how to break free, Troubadour Publishing Ltd.

2014 Coleman RA (Ed). Human based systems for translational research. 2014, Royal Society of Chemistry.

Book chapters

2020

Pound P. Animal models and the search for drug treatments for traumatic brain injury. In
Johnson L, Fenton A, Shriver A (Eds) Neuroethics and nonhuman animals. 2020, Springer,
Switzerland. Link to ebook

2019

Archibald K, Coleman C, Drake T. Replacing animal tests to improve safety for humans. In Herrmann K and Jayne K. (eds). Animal Experimentation: Working Towards a Paradigm Change. Leiden/ Boston: Brill; 2019. See book (open access)

Ram R. Extrapolation of animal research data to humans: an analysis of the evidence. In Herrmann K and Jayne K. (eds). Animal Experimentation: Working Towards a Paradigm Change. Leiden/ Boston: Brill; 2019. See book (open access)

Pound P. Animal models: problems and prospects. Chapter 18, p239-52. In Fischer B (Ed) The Routledge Handbook of Animal Ethics. 2019, Taylor and Francis, New York. https://doi.org/10.4324/9781315105840

2018

Kenna JG, Ram R. Safety assessment of pharmaceuticals. In M Balls, R Combes (eds) The history of alternative test methods in toxicology pp167-174. 2018, Academic Press, London. https://www.elsevier.com/books/the-history-of-alternative-test-methods-in-toxicology/balls/978-0-12-813697-3

Kenna JG, Waterton JC, Baudy A, Galetin A, Hines CD, Hockings P, Patel M, Scotcher D, Sourbron S, Ziemian S, Schuetz G. Noninvasive Preclinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury. In Chen M., Will Y. (eds) Drug-Induced Liver Toxicity. Methods in Pharmacology and Toxicology. 2018 Humana Press, New York, NY.https://doi.org/10.1007/978-1-4939-7677-5_30

Light DS, Aleo MD, Kenna JG. Interpretation, Integration, and Implementation of In Vitro Assay Data: The Predictive Toxicity Challenge. In Chen M., Will Y. (eds) Drug-Induced Liver Toxicity. Methods in Pharmacology and Toxicology. 2018 Humana Press, New York, NY.
https://doi.org/10.1007/978-1-4939-7677-5_17

2016

Kenna JG, Thompson RA. Integrated reactive metabolite strategies. Chapter 5. In Iverson SL, Smith DA (Eds) Metabolite Safety in Drug Development. 2016 John Wiley and Sons. DOI:10.1002/9781118949689
https://doi.org/10.1002/9781118949689.ch5

Letters to scientific journals

2011

Archibald K, Coleman R, Foster C. Open letter to UK Prime Minister David Cameron and Health Secretary Andrew Lansley on safety of medicines. The Lancet. 2011;377(9781):1915.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60802-7/fulltext?rss=yes&utm_source=feedblitz&utm_medium=FeedBlitzEmail&utm_content=196607&utm_campaign=0

Archibald K, Baxter AD, BeruBe K, Bunton D, Clotworthy M, Coleman R, Foster CS, Hillier C, McFarlane M, Patel A, Pierscionek B. Safety of medicine and the use of animals in research. Lancet 2011;378(9802):e2.
PDF: Archibald et al 2011

2007

Archibald K. Moving away from animal research for clinical benefit. BMJ January 29, 2007.

Archibald K. Medical progress: thanks to clinical research, not animal research. BMJ January 23, 2007.

2004

Archibald K. Animal testing: call for open, scientific debate. The Lancet. 2004;364(9444):1486.
PDF: Archibald 2004

Letters to newspapers and magazines

2016

Archibald K, Kenna G, Pierscionek B. Brain models could replace primates. The New Scientist 2016; 231(3083):52-52
https://www.newscientist.com/letter/mg23130830-800-8-brain-models-could-replace-primates/

2015

Archibald K et al. Animal Research. The Times. July 4, 2015. https://www.thetimes.co.uk/article/animal-research-gsw3klcd27b

2014

Archibald K et al. Using animals to test drugs is outdated and unreliable. The Observer. August 31, 2014.
https://www.theguardian.com/theobserver/2014/aug/31/animal-testing-drugs-new-tech-letters

Archibald K et al. Politicians impeding medical advances. The Sunday Times. September 7th, 2014.

2013

Archibald K. Scientists versus evidence. The New Statesman. January 4, 2013.

2012

Archibald K. New techniques mean animal testing is totally out of date. The Observer. August 5, 2012.

Archibald K. Interview with KA about Safer Medicines. Live a Better Life magazine. Issue 1, November 2012.

2010

Archibald K. Vivisection value. The New Scientist 2010; 207(2767): 28-29

2009

Archibald K. Animal testing futile. The Herald. January 12, 2009.

2008

Archibald K. Alternatives to animal experimentation. The Herald. November 17, 2008.

Clotworthy M. Hypocrisy on animal tests. The Scotsman. November 7, 2008.

Clotworthy M. The Telegraph. October 30, 2008.

Archibald K.  Monkey tests don’t work. The Daily Mail. May 29, 2008.

Clotworthy M. Testing animal tests. The New Scientist 2008 (2652): 16-17.

2006

Archibald K. Monkey trials are doomed to fail. Mail on Sunday. December 17, 2006.

Archibald K. Animal testing helps us discover cures for mice, not men. The Independent. November 18, 2006.

Archibald K. No need for monkeys. New Scientist 2006; 191(2558): 26 https://www.newscientist.com/letter/mg19125580-100-no-need-for-monkeys/

Archibald K. Trial by Species. New Scientist 1 February 2006. https://www.newscientist.com/letter/mg18925370-600-trial-by-species/

Bailey J. Drugs Blunder. The Independent on Sunday, 2 April 2006.

Articles in newspapers and magazines

2016

Archibald K. Of mice but not men. What Doctors Don’t Tell You. August 2016 (Vol. 27 Issue 5)
https://www.wddty.com/magazine/2016/august/of-mice-but-not-men.html

2014

Coleman RA, Tsaioun K, Archibald K. A pragmatic comparison of human in vitro with animal in vivo approaches to predicting toxicity in human medicines. March 27, 2014.
http://alttox.org/a-pragmatic-comparison-of-human-in-vitro-with-animal-in-vivo-approaches-to-predicting-toxicity-in-human-medicines/

2012

Archibald K, Coleman RA. A humane solution. How to stop adverse drug reactions. The New Scientist 2012: 216 (2895): 32-33.

Coleman RA, Archibald K.  How human biology can prevent drug deaths. The New Scientist 12 December 2012
https://www.newscientist.com/article/mg21628950.200-how-human-biology-can-prevent-drug-deaths/

2009

Archibald K. The dead end of animal research. Guardian 7 Aug. 2009
https://www.theguardian.com/commentisfree/2009/aug/07/animal-testing-medical-research

Clotworthy M. Could we have safer medicines through non-animal testing? Scientists for Global Responsibility Newletter. Issue 37, Spring 2009.
PDF: Clotworthy 2009

Archibald K. Which would you trust to protect your health? Lifescape Magazine 2009.
PDF: Archibald 2009

2008

Clotworthy M. Safer Medicines. Lifescape Magazine. Feb/ March 2008.
PDF: clotworthy 2008

2006

Archibald K. It’s time to test the testers. Guardian 5 May 2006.
https://www.theguardian.com/education/2006/may/05/highereducation.uk

Archibald K. Vivisection is not a reliable means of testing human drugs. The Oxford Student.
https://www.safermedicines.org/_assets/images/oxford_student_06.jpg

2005

Archibald K. Animal testing: science or fiction. The Ecologist, 2005 May:14-7. http://www.safermedicines.org/articles/static03.shtml

Archibald K. Test people, not animals. The New Scientist 2005; 187(2518): 24.

Archibald K. Animal testing for drug safety is unreliable. Spiked. 3 March, 2005.
https://www.safermedicines.org/showarticles.php?pid=42

Blogs

2019

Pandora Pound and Merel Ritskes-Hoitinga. Let’s work together to explore the evidence base for all preclinical research methodologies. In response to: Drug discovery and preclinical drug development – have animal studies really failed?

Pandora Pound and Merel Ritskes-Hoitinga. Species differences: the elephant in the room. Blog for NEAVS  https://neavs.org/blog/2019/1/23/species-differences-the-elephant-in-the-room

2018

Pound, P. The problem of evidence in pre-clinical animal research: how systematic reviews can help. Blog for the Animals in Science Policy Institute
https://www.animalsinscience.org/blog/problem-evidence-pre-clinical-animal-research-systematic-reviews-can-help/

2015

Kathy Archibald. Replacing animal testing – the future is already here. 4-part blog for Veganuary.
https://veganuary.com/blog/replacing-animal-testing-future-already-part-1/

Articles in journals and magazines about Safer Medicines

2010

Finn, K. New UK ethics debate on human tissue sharing. Regulatory Affairs Journal (RAJ) Pharma. 19 July 2010
https://www.safermedicines.org/showarticles.php?pid=45

2009

Brizmohun, N. Is the End in Sight for Animal Trials? Regulatory Affairs Journal (RAJ) Pharma. 5 Feb 2009.
https://www.safermedicines.org/showarticles.php?pid=9

Bhogal, N. Speed and safety in drug discovery: a brief conference report. Alternatives to laboratory animals: ATLA. 2009;37(1):143-5.
PDF: Bhogal 2009

McColl, I. Testing conditions. The House Magazine. 19 October 2009.
PDF: McColl 2009

2007

Matthews, R. Why cats should all say no to an aspirin. Daily Express. July 11 2007.
https://www.safermedicines.org/showarticles.php?pid=19

2006

Stephenson, J. While the debate rages on, lab rats are still suffering. The Independent. 16 January 2006.
https://www.safermedicines.org/showarticles.php?pid=31

2005

James, P. Scientist: Animal tests don’t work. The Newcastle Journal. 24 Feb 2005.
https://www.safermedicines.org/showarticles.php?pid=43

Meiklem, PJ. Testing on animals has slowed search for cures claims leading UK scientist. Big Issue Scotland. 25 July 2005.
https://www.safermedicines.org/showarticles.php?pid=38

Stephenson, J. A victory for good sense – and guinea pigs. The Independent. 29 August 2005.
https://www.safermedicines.org/showarticles.php?pid=36

Smith, K. The human guinea pigs. Could animal testing become redundant? Some scientists believe technology has the answer. The Times. 17 December 2005
https://www.safermedicines.org/showarticles.php?pid=32

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