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4 produkter
4 produkter
1 096 kr
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The timing of toxicological studies in relation to the clinical evaluation of new medicines is a key topic for strategic planners in the industry and those involved with harmonization. Resolving the anomalies between different regulatory authorities should eliminate redundant testing on animals and improve the efficiency of the developmental process by encouraging single international strategies. To aid industry in reaching a consensus, the Centre for Medicines Research has brought together representatives of the pharmaceutical industry from Europe, Japan and the USA to give a comprehensive account of current international industry positions on the subject. The contributions in this text review the situation and address the clinical and strategic requirements of the pre-clinical programme. Personal and consensus proposals on the toxicity studies required to initiate clinical investigations, the timing of reproductive toxicity tests and the duration of repeat-dose studies to support clinical development are provided.
Relevance of Ethnic Factors in the Clinical Evaluation of Medicines
Proceedings of a Workshop held at The Medical Society of London, UK, 7th and 8th July, 1993
Häftad, Engelska, 2012
552 kr
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For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.
1 096 kr
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Over the past twelve years, the Centre for Medicines Research has held a series of Workshops on a number of topics related to the drug discovery and development process. The major objective of these Workshops has been to provide an international forum for regula tory, academic and industry representatives to debate together, and suggest solutions to, specific problems. The meeting reported in this volume represents a departure from this approach, in that the par ticipants were drawn largely from the pharmaceutical industry. Senior clinicians, pharmacologists and toxicologists from companies in Europe, the USA and Japan met in May 1994 to discuss a scientific rationale for the conduct of toxicity studies to support the clinical development of new medicines, and to begin to work towards an industry consensus. Achievement of such a consensus is seen as an important step in the process leading towards international harmon isation of the recommendations on the timing of toxicity studies in relation to clinical trials.
Improving the Regulatory Review Process: Assessing Performance and Setting Targets
Häftad, Engelska, 2012
493 kr
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At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance. The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.