Strategic Focus on 3R Principles Reveals Major Reductions in the Use of Animals in Pharmaceutical Toxicity Testing
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{"title"=>"Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing", "type"=>"journal", "authors"=>[{"first_name"=>"Elin", "last_name"=>"Törnqvist", "scopus_author_id"=>"55743870400"}, {"first_name"=>"Anita", "last_name"=>"Annas", "scopus_author_id"=>"6602630565"}, {"first_name"=>"Britta", "last_name"=>"Granath", "scopus_author_id"=>"57191762180"}, {"first_name"=>"Elisabeth", "last_name"=>"Jalkesten", "scopus_author_id"=>"36893941900"}, {"first_name"=>"Ian", "last_name"=>"Cotgreave", "scopus_author_id"=>"35466125500"}, {"first_name"=>"Mattias", "last_name"=>"Öberg", "scopus_author_id"=>"7003468621"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-84904637119", "sgr"=>"84904637119", "pui"=>"373596240", "isbn"=>"10.1371/journal.pone.0101638", "pmid"=>"25054864", "doi"=>"10.1371/journal.pone.0101638"}, "id"=>"14e157f2-ef37-3904-982c-989644058a4c", "abstract"=>"The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order to safeguard animal welfare. In the present study we have studied the systematic application of 3R principles to toxicological research in the pharmaceutical industry, with particular focus on achieving reductions in animal numbers used in regulatory and investigatory in vivo studies. The work also details major factors influencing these reductions including the conception of ideas, cross-departmental working and acceptance into the work process. Data from 36 reduction projects were collected retrospectively from work between 2006 and 2010. Substantial reduction in animal use was achieved by different strategies, including improved study design, method development and project coordination. Major animal savings were shown in both regulatory and investigative safety studies. If a similar (i.e. 53%) reduction had been achieved simultaneously within the twelve largest pharmaceutical companies, the equivalent reduction world-wide would be about 150,000 rats annually. The results point at the importance of a strong 3R culture, with scientific engagement, collaboration and a responsive management being vital components. A strong commitment in leadership for the 3R is recommended to be translated into cross-department and inter-profession involvement in projects for innovation, validation and implementation. Synergies between all the three Rs are observed and conclude that in silico-, in vitro- and in vivo-methods all hold the potential for applying the reduction R and should be consequently coordinated at a strategic level.", "link"=>"http://www.mendeley.com/research/strategic-focus-3r-principles-reveals-major-reductions-animals-pharmaceutical-toxicity-testing", "reader_count"=>54, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>2, "Librarian"=>1, "Researcher"=>6, "Student > Doctoral Student"=>4, "Student > Ph. D. 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Student"=>14, "Student > Postgraduate"=>4, "Other"=>4, "Student > Master"=>7, "Student > Bachelor"=>7, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Agricultural and Biological Sciences"=>9, "Business, Management and Accounting"=>1, "Veterinary Science and Veterinary Medicine"=>1, "Chemistry"=>5, "Computer Science"=>1, "Earth and Planetary Sciences"=>1, "Engineering"=>5, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>8, "Nursing and Health Professions"=>5, "Medicine and Dentistry"=>5, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Social Sciences"=>1, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>5}, "Social Sciences"=>{"Social Sciences"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}, "Engineering"=>{"Engineering"=>5}, "Chemistry"=>{"Chemistry"=>5}, "Earth and Planetary Sciences"=>{"Earth and Planetary Sciences"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>9}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>5}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>8}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>1}}, "reader_count_by_country"=>{"Sweden"=>2, "United Kingdom"=>1, "France"=>1}, "group_count"=>5}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1606466"], "description"=>"<p>NA = Not analysed</p><p>a) Not possible to estimate as the test/study is performed when requested and this varies substantially between years.</p><p>b) Not possible to estimate the effects on reduction of animal use or replacement of animal studies today.</p><p>c) Not possible to estimate as the number of biomarker studies and study design varies depending on present drug projects and safety assessment issues. Probably a reduction of more than one hundred animals per year. To be evaluated after 2–3 years.</p><p>d) Possible risk for interference with observations of clinical signs is addressed and during scientifically investigation and evaluation before implementing the method as default.</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation"], "article_id"=>1115579, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.t002", "stats"=>{"downloads"=>1, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Projects_related_to_development_of_new_methods_the_reduction_per_study_and_estimated_annual_reduction_/1115579", "title"=>"Projects related to development of new methods, the reduction per study and estimated annual reduction.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606465"], "description"=>"<p>NA = Not analysed</p><p>a) Not possible to estimate as the number of studies varies between years. To be evaluated after 2–3 years.</p><p>b) Not possible to estimate as the number of investigative studies varies between years. Probably an annual reduction of more than hundred rats. To be evaluated after 2–3 years.</p><p>c) Not possible to estimate as the number of method development and/or validation studies varies between years. Probably an annual reduction of more than one hundred rats. To be evaluated after 2–3 years.</p><p>d) Not possible to estimate as the number of biomarker studies varies depending on present drug projects and safety assessment issues. Probably an annual reduction of more than one hundred rats. To be evaluated after 2–3 years.</p><p>e) Not possible to estimate as the projects vary in nature.</p><p>f) Risk for too low exposure for micronucleus evaluation is addressed and during scientifically investigation and validation before implementation as default.</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation"], "article_id"=>1115578, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.t003", "stats"=>{"downloads"=>2, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Projects_related_to_coordination_the_reduction_per_study_and_estimated_annual_reduction_/1115578", "title"=>"Projects related to coordination, the reduction per study and estimated annual reduction.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606460"], "description"=>"<p>The unit comprised eight departments and performed preclinical toxicity studies and evaluations to support the company's various drug projects to predict potential side effects before e.g. clinical trials in man.</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation"], "article_id"=>1115573, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.g001", "stats"=>{"downloads"=>2, "page_views"=>54, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Schematic_illustration_of_the_Safety_Assessment_Research_Unit_at_AstraZeneca_S_246_dert_228_lje_/1115573", "title"=>"Schematic illustration of the Safety Assessment Research Unit at AstraZeneca, Södertälje.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606464"], "description"=>"<p>NA = Not analysed</p><p>a) Not possible to estimate as the routine was implemented just before the end of the investigated period.</p><p>b) Not possible to estimate as the design and number of investigative studies varies a lot between years. To be evaluated after 2–3 years.</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation", "improvements"], "article_id"=>1115577, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.t001", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Projects_related_to_improvements_in_study_design_the_reduction_per_study_and_estimated_annual_reduction_/1115577", "title"=>"Projects related to improvements in study design, the reduction per study and estimated annual reduction.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606462"], "description"=>"<p>Actual number of animals used in 2009 (black bars) compared with the estimated number of animals if no reduction projects would have been implemented (grey bars).</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation", "animals", "toxicity", "studies"], "article_id"=>1115575, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.g003", "stats"=>{"downloads"=>1, "page_views"=>30, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Estimated_reduction_in_number_of_animals_used_in_toxicity_studies_at_Safety_Assessment_Research_Unit_/1115575", "title"=>"Estimated reduction in number of animals used in toxicity studies at Safety Assessment Research Unit.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606463"], "description"=>"<p>The number of projects specified according to category of the project (a) and specified in relation to the participation in projects with multiple or single departments (b).</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation", "linked"], "article_id"=>1115576, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.g004", "stats"=>{"downloads"=>2, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Projects_linked_to_the_department_ownership_a_or_the_participation_b_of_each_project_/1115576", "title"=>"Projects linked to the department ownership (a) or the participation (b) of each project.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-07-23 03:49:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1606461"], "description"=>"<p>Total number of rats used in toxicity studies at the Safety Assessment Research Unit (black line) and total number of reported regulatory toxicity studies, one month or longer (black bars) and shorter investigative toxicity/mechanistic studies (grey bars) during the years 2006–2010.</p>", "links"=>[], "tags"=>["bioethics", "toxicology", "pharmacology", "Drug research and development", "drug discovery", "Drug regulation", "rats", "toxicity", "studies", "longer", "shorter", "investigative", "years"], "article_id"=>1115574, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Elin Törnqvist", "Anita Annas", "Britta Granath", "Elisabeth Jalkesten", "Ian Cotgreave", "Mattias Öberg"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0101638.g002", "stats"=>{"downloads"=>0, "page_views"=>19, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Total_number_of_rats_used_in_toxicity_studies_at_the_Safety_Assessment_Research_Unit_black_line_and_total_number_of_reported_regulatory_toxicity_studies_one_month_or_longer_black_bars_and_shorter_investigative_toxicity_mechanistic_studies_grey_bars_durin/1115574", "title"=>"Total number of rats used in toxicity studies at the Safety Assessment Research Unit (black line) and total number of reported regulatory toxicity studies, one month or longer (black bars) and shorter investigative toxicity/mechanistic studies (grey bars) during the years 2006–2010.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-07-23 03:49:28"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"40", "full-text"=>"44", "pdf"=>"6", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"7"}
  • {"unique-ip"=>"67", "full-text"=>"76", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"8"}
  • {"unique-ip"=>"80", "full-text"=>"86", "pdf"=>"37", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"9"}
  • {"unique-ip"=>"115", "full-text"=>"138", "pdf"=>"33", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2020", "month"=>"10"}

Relative Metric

{"start_date"=>"2014-01-01T00:00:00Z", "end_date"=>"2014-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences/Organisms", "average_usage"=>[310]}, {"subject_area"=>"/Biology and life sciences/Physiology", "average_usage"=>[280]}, {"subject_area"=>"/Biology and life sciences/Toxicology", "average_usage"=>[266, 408]}, {"subject_area"=>"/Medicine and health sciences/Clinical medicine", "average_usage"=>[282]}]}
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