Possibilities for refinement and reduction: future improvements within regulatory testing.
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Approaches and challenges to refining and reducing animal use in regulatory testing are reviewed. Regulatory testing accounts for the majority of animals reported in the most painful and/or distressful categories in the United States and Canada. Refinements in testing, including the use of humane endpoints, are of increasing concern. Traditional approaches to reduction (e.g., improving experimental design) are being supplemented with complementary approaches, such as the use of tier testing to eliminate some chemicals prior to in vivo testing. Technological advances in telemetry and noninvasive techniques will help decrease either the demand for animals in testing or animal suffering. Further decreases in animal use will stem from international harmonization and coordination of testing programs. Progress in refinement and reduction faces a variety of broad challenges, including limited funding for research. In the specific area of refinement, a key challenge is the issue of distress (as distinct from pain). In the area of reduction, the practice of using unjustifiably high numbers of animals from small species (e.g., rodents) should be challenged. One case study of the use of carbon dioxide as a euthanasia agent illustrates the need for further analysis and research. Notwithstanding the complexities and challenges, the potential for refinement and reduction in regulatory testing is encouraging. (+info)
Future improvements and implementation of animal care practices within the animal testing regulatory environment.
(34/888)
Animal welfare is an increasingly important concern when considering biomedical experimentation. Many of the emerging regulations and guidelines specifically address animal welfare in laboratory animal care and use. The current revision of the appendix of the European Convention, ETS123 (Council of Europe), updates and improves on the current animal care standardization in Europe. New guidelines from the Organisation for Economic Co-operation and Development and the European Federation of Pharmaceutical Industries Association focus specifically on safety testing. These guidelines will affect the way toxicity studies are conducted and therefore the global drug development process. With the 3Rs principles taken into account, consideration regarding animal welfare will demand changes in animal care practices in regulatory safety testing. The most significant future improvements in animal care and use practices are likely to be environmental enrichment, management of animal pain and distress, and improved application of the humane endpoints. Our challenge is to implement respective guidelines based on scientific data and animal welfare, through a complex interplay of regulatory objective and public opinion. The current goal is to work toward solutions that continue to provide relevant animal models for risk assessment in drug development and that are science based. In this way, future improvements in animal care and use practices can be founded on facts, scientific results, and analysis. Some of these improvements become common practice in some countries. International harmonization can facilitate the development and practical application of "best scientific practices" by the consensus development process that harmonization requires. Since the implementation of good laboratory practices (GLP) standards in safety testing, these new regulations and recommendations represent a new way forward for animal safety studies. (+info)
Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.
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Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also discussed are the participation of the US Food and Drug Administration (FDA) in the ICCVAM process and that agency's approach to the application and implementation of ICCVAM-recommended methods. (+info)
ICH guidelines--implementation of the 3Rs (refinement, reduction, and replacement): incorporating best scientific practices into the regulatory process.
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An overview of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is described. ICH was established through cooperation of the regulatory agencies and industrial parties of three main regions involved in pharmaceuticals: the European Union, the United States, and Japan. The purpose of the ICH is to make recommendations to achieve greater harmonization regarding interpretation and application of technical guidelines and requirements for product registration in an effort to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The main purpose of ICH was not to foster the 3Rs per se; however, harmonization of guidelines has eliminated duplications of similar tests to satisfy the specific requirements of each region. The ICH process has contributed to mutual understanding of the regulatory requirements and has decreased the number of unnecessary animal experiments. Specific examples of the contributions of ICH harmonization to the 3Rs are described. (+info)
Principles and guidelines for the development of a science-based decision making process facilitating the implementation of the 3Rs by governmental regulators.
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National government establishments, including regulatory agencies, are part of national science systems, which are a subset of larger national innovation systems. The forces that have influenced the basic roles of national government establishments in five countries over the past 10 yr are reviewed on the basis of a study commissioned by Industry Canada in 1999 for the Council of Science and Technology Advisors to the Canadian government. The most significant response among countries has been found to be the financial and managerial restructuring of government science and technology establishments driven by the push toward self-financing. Trends in the roles of government science and technology in six areas are also ranked, with increasing the health and safety of the nation, providing support to industry and participating in international cooperation occupying the first three positions. Potential ramifications of these trends on the implementation of the concept of replacement, reduction, and refinement (the 3Rs) in ensuring the ethical use of animals in regulatory testing are discussed. Science advice and its role in governmental decision making is reviewed on the basis of the 1999 Report of the Council of Science and Technology Advisors, Science Advice for Government Effectiveness. Six principles developed for the effective use of science advice in making regulatory decision have been adapted and are proposed with accompanying guidelines as a framework for the development of a science-based decision making process to facilitate the implementation of the 3Rs by governmental regulators. The proposed series of principles and guidelines are designed to reflect the rapidly evolving and complex context for government decision making, and to remain consistent across government departments and across nations. (+info)
International efforts spotlight traditional, complementary, and alternative medicine.
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Affordable, available, and ever more popular at home and abroad, "alternative" healers are finally getting positive attention from Western practitioners. This rapprochement has enormous implications for public health worldwide. (+info)
The guards themselves.
(39/888)
If we agree that, in the present climate of fear of bioterrorism, some restrictions on the conduct and/or publication of certain types of biological research are likely, it is to our advantage to preempt government action by devising for ourselves restrictions that we can live with, then the inevitable question becomes: how should these restrictions be administered? (+info)
Assessing the evidence submitted in the development of a workplace smoking regulation: the case of Maryland.
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OBJECTIVE: This study compared the characteristics of the basic science, biomedical, and socioeconomic literature submitted in 1993-1994 by supporters and opponents of the proposed workplace regulation of tobacco smoke developed by the Maryland Occupational Safety and Health (MOSH) Advisory Board. METHODS: The authors retrospectively analyzed 544 written publications submitted to the MOSH Advisory Board regarding the proposed workplace regulation of tobacco smoke. Outcome measures included the type and year of publication and, for journal articles, the journal's peer review policy and impact factor. RESULTS: Supporters of regulation submitted fewer documents (n = 164) than opponents (n = 380). Supporters of regulation submitted a lower proportion of conference proceedings and a higher proportion of government reports. The publications submitted to the regulators by the supporters of regulation were more recently published than the materials submitted by opponents. Journal articles represented more than half of the publications submitted; most were peer-reviewed. Supporters of regulation submitted articles from journals with higher impact factors (median impact factor 2.78) than did opponents of regulation (median 1.66; p = 0.0005), and articles that were published more recently (median year of publication 1990) than those submitted by opponents (median 1989; p = 0.0001). CONCLUSIONS: Public health advocates should highlight the scientific evidence base that supports tobacco control regulations. Public health advocates should encourage and support regulatory officials' use of the criteria of peer review, impact factor, and date of publication to prioritize their review of submitted documents in order to base policy on the best available evidence. (+info)