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Putting Animal Welfare Principles and 3Rs Into Action

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Putting Animal Welfare Principles and 3Rs Into Action Putting animal welfare principles and 3Rs into action European Pharmaceutical Industry Report 2016 Update PUTTING ANIMAL WELFARE PRINCIPLES AND 3Rs INTO ACTION - European Pharmaceutical Industry Report - 2016 Update Beyond Compliance Leading by Example Open Communications Practice Science Training Sharing Enforcing Dialogue Reporting Is this a brochure or is this a website? This has been produced as an interactive PDF which can be used just like any normal PDF, and it is therefore easy to print and read like a brochure; however if you are using it online or on a tablet, you can use the interactive features just like a website to navigate through each section: Click on the header buttons (Beyond Compliance; Leading by Example; Open Communications) allows you to jump to a new section Some pages contain hyperlinks, which appear as coloured text within the body text 2 PUTTING ANIMAL WELFARE PRINCIPLES AND 3Rs INTO ACTION - European Pharmaceutical Industry Report - 2016 Update Beyond Compliance Leading by Example Open Communications Practice Science Training Sharing Enforcing Dialogue Reporting The pharmaceutical industry is committed fully The use of animals in research remains a the lives of the people and animals that stand to the key principles of the 3Rs (Reducing the highly sensitive issue. While it is desirable to benefit from the research. number of animals used, Refining experiments to replace the use of animals in research & to minimise the impact on animals, and development, research involving animals Here we introduce you to our 4th report Replacing animal experiments wherever continues to be necessary to protect human which gives an overview of EFPIA and its possible with alternatives), and through them, and animal, and environmental health; maintain member’s activities in putting into action animal to ensuring high standards of animal welfare in the ability to respond to regulatory demands, welfare principles and the 3Rs of reduction, the research process. and; understand the causes of diseases and refinement and replacement. We give an functioning of complex biological systems in the extensive overview of the work taking place in This concept of the 3Rs was developed some body. Furthermore, Europe must remain a world the industry. With this in mind, the examples 50 years ago, and continues to be taken up leader in medical research and innovation to included in this report highlight the activities and implemented within the pharmaceutical address the unmet medical needs of its citizens going beyond compliance, and examples sector where the ongoing aim is to improve and to preserve its capacity to shape its health where we are leading on 3Rs and transparency the quality of life for people by developing strategies. through open communication. new products and services for the diagnosis and treatment of diseases, while ensuring high The pharmaceutical industry along with all welfare to the animals involved. Furthermore, stakeholders have responsibilities to play in The previous reports “Putting Animal Welfare the pharmaceutical industry strongly supports the development, uptake and dissemination of Principles and 3Rs into Action” are available the Directive 2010/63/EU on the protection work on 3Rs and those taken by industry are here. of animals used for scientific purposes which visibly highlighted in this report. We strive to has enhanced animal welfare standards go beyond what is legally required and work to and mandated the application of reduction, implement 3Rs to ensure high animal welfare refinement and replacement (‘3Rs’) across the and high quality science and ultimately improve EU. 3 PUTTING ANIMAL WELFARE PRINCIPLES AND 3Rs INTO ACTION - European Pharmaceutical Industry Report - 2016 Update Beyond Compliance Leading by Example Open Communications Practice Science Training Sharing Enforcing Dialogue Reporting Beyond Compliance Leading by Example Open Communication 3Rs and welfare in everyday practice Dissemination beyond own We tell what we do and engage in department and own establishment open dialogue with interested parties drives improvement in welfare and Science and technology drive 3Rs and general quality of science welfare - We invest continuously in Communicating progress made in changing research paradigms animal welfare activities In a global world, we exchange with and learn from international partners to drive Staff training is an essential element of convergence good science and good welfare Full and correct implementation of Directive 2010/63/EC on the protection of animals used for scientific purposes is the responsibility and endeavor of the whole scientific community 4 PUTTING ANIMAL WELFARE PRINCIPLES AND 3Rs INTO ACTION - European Pharmaceutical Industry Report - 2016 Update Beyond Compliance Leading by Example Open Communications Practice Science Training Sharing Enforcing Dialogue Reporting Beyond Compliance 3Rs and welfare in everyday practice: Researchers go beyond the regulatory requirements to develop systems leading to improved 3Rs and animal welfare in every day practice Refinement model to evaluate the non- interactions occur in humans. An innovative specific side effects of anti-body drug study was conducted to show that there conjugates moving away from use of was no need to use an animal with the non-human primates (Reduction and same specific interactions as in humans. Refinement) Using rats rather than NHP is a significant refinement and substantial contribution Antibody Drug Conjugates (ADCs) are to reducing the number of NHP used in targeted antibodies that are connected to a research very potent chemotherapeutic drug that can be used in treating certain cancers. The ADC In vitro gastrointestinal in vitro allows the treatment to be delivered directly models to mimic processes in humans to the site where the tumour is. (Replacement) ADCs are challenging to develop as they When developing human medicines, there have complex structures and are one is a need for methods to rank different of the leading causes of failure in their formulations for the medicines to be development are unexpected, non- specific delivered in clinical trials. Mostly this is TNO have developed in vitro gastrointestinal Implanted cannula for serial collection side effects. These occur when the antibody done using simple test-tube assays such as models which are multi-compartmental of cerebrospinal fluid reducing animal used in the ADC binds to healthy tissue dissolution rates. These results occasionally dynamic non-animal systems that simulate use (Reduction) also. need to be verified by assessing the the successive dynamic processes in the kinetics in a live animal. However, species stomach, small and large intestine. This The development of a serial collection To overcome this challenge, a model in rats differences in the gastrointestinal tract in vitro system allows the testing of of cerebrospinal fluid (CSF) and plasma was developed to evaluate the non-specific are well known (e.g. differing pH, gastric formulations being developed for human samples via implanted cannula in freely side effects. Normally, the complexity and emptying times), which may introduce use, in a system that mimics the human moving laboratory rats has led to a decrease specificity of ADCs necessitate the use of difficulties in interpreting results for human gastrointestinal tract instead of doing in in animal numbers. non-human primates where these specific relevance. vivo pharmacokinetic studies. 5 PUTTING ANIMAL WELFARE PRINCIPLES AND 3Rs INTO ACTION - European Pharmaceutical Industry Report - 2016 Update Beyond Compliance Leading by Example Open Communications Practice Science Training Sharing Enforcing Dialogue Reporting Beyond Compliance The CSF sample is a useful tool for the compound is present in the groups of bespoke studies that have illustrated that translational analysis of biological animals being tested and to understand micro-sampling has no or negligible impact efficacy markers and pharmacokinetic how the degree of systemic exposure on the parameters assessed across many drug exposure. It shows how the drug may be linked to any toxicological effects study types. Many of these have been candidate that is developed for treating observed. The blood (plasma or serum) published enabling a broader uptake of the brain diseases produces desired effects in concentration data generated from each technique and the pharmaceutical industry the brain, such as elevation of dopamine sample is used to derive toxicokinetic (TK) has contributed to a regulatory question in Parkinson’s disease. Up to six samples data and regulatory guidance dictates and answer document to encourage the use of CSF at different time points can be generally how and when these data are of micro-sampling where possible. collected from the same animal, which needed during compound development. reduces significantly the number of animals Change in housing conditions to allow needed, as compared with terminal CSF The information is used to establish safety urine samples to be taken in own cages sampling, which requires an animal per margins for human clinical trials. The reducing stress (Refinement) time point. This new technique improves largest influence on animal numbers used the quality of data because baseline and in safety assessment, particularly rodents, In many studies, e.g. safety studies, urine treated CSF samples are collected in the is the collection of samples for TK analysis. is collected so that urine concentration same animal
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