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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines
Da: Zubal-Books, Since 1961, Cleveland, OH, U.S.A.
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Condizione: Good. *Price HAS BEEN REDUCED by 10% until Tuesday, May 26 (holiday sale item)* 284 pp., Hardcover, ex library, else text clean and binding tight. - If you are reading this, this item is actually (physically) in our stock and ready for shipment once ordered. We are not bookjackers. Buyer is responsible for any additional duties, taxes, or fees required by recipient's country.
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Timing of Toxicological Studies to Support Clinical Trials, The
Lingua: Inglese
Editore: Kluwer Academic Publishers, 1994
ISBN 10: 0792388720 ISBN 13: 9780792388722
Da: Fireside Bookshop, Stroud, GLOS, Regno Unito
Membro dell'associazione: PBFA
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Aggiungi al carrelloCloth/Laminated Boards. Condizione: Very Good. Type: Book 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. Small mark at base of spine.128pp.
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets
Lingua: Inglese
Editore: Kluwer Academic Publishers, 1998
ISBN 10: 0792387317 ISBN 13: 9780792387312
Da: Fireside Bookshop, Stroud, GLOS, Regno Unito
Membro dell'associazione: PBFA
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Aggiungi al carrelloCloth/Laminated Boards. Condizione: Very Good. Type: Book 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 12th 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 summarizes 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. 163pp.
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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
Da: GreatBookPrices, Columbia, MD, U.S.A.
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Improving the Regulatory Review Process : Assessing Performance and Setting Targets
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
Da: California Books, Miami, FL, U.S.A.
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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines: Proceedings of a Workshop held at The Medical Society of London, UK, 7th and ... 1993 (Centre for Medicines Research Workshop)
Da: California Books, Miami, FL, U.S.A.
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Improving the Regulatory Review Process : Assessing Performance and Setting Targets
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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines: Proceedings of a Workshop held at The Medical Society of London, UK, 7th and ... 1993 (Centre for Medicines Research Workshop)
Da: Ria Christie Collections, Uxbridge, Regno Unito
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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Improving the Regulatory Review Process
Da: Books Puddle, New York, NY, U.S.A.
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Condizione: New. pp. xix + 163.
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines (Centre for Medicines Research Workshop)
Da: Chiron Media, Wallingford, Regno Unito
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Improving the Regulatory Review Process : Assessing Performance and Setting Targets
Da: GreatBookPricesUK, Woodford Green, Regno Unito
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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
Da: GreatBookPricesUK, Woodford Green, Regno Unito
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Paperback or Softback)
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Paperback or Softback. Condizione: New. Improving the Regulatory Review Process: Assessing Performance and Setting Targets. Book.
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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines: Proceedings of a Workshop Held at the Medical Society of London, Uk, 7th and (Paperback or Softback)
Da: BargainBookStores, Grand Rapids, MI, U.S.A.
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Paperback or Softback. Condizione: New. The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines: Proceedings of a Workshop Held at the Medical Society of London, Uk, 7th and. Book.
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Improving the Regulatory Review Process : Assessing Performance and Setting Targets
Da: GreatBookPricesUK, Woodford Green, Regno Unito
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
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Aggiungi al carrelloPaperback. Condizione: Brand New. 1997 edition. 163 pages. 9.45x6.30x0.43 inches. In Stock.
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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines (Centre for Medicines Research Workshop)
Da: Ria Christie Collections, Uxbridge, Regno Unito
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Improving the Regulatory Review Process: Assessing Performance and Setting Targets (Centre for Medicines Research Workshop)
Da: Ria Christie Collections, Uxbridge, Regno Unito
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Timing of Toxicological Studies to Support Clinical Trials
Da: GreatBookPrices, Columbia, MD, U.S.A.
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. The 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 | S. R. Walker (u. a.) | Taschenbuch | xviii | Englisch | 2013 | Springer | EAN 9789401046213 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. Improving the Regulatory Review Process: Assessing Performance and Setting Targets | N. McAuslane (u. a.) | Taschenbuch | Centre for Medicines Research Workshop | xix | Englisch | 2012 | Springer | EAN 9789401060424 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.
-
The 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
Lingua: Inglese
Editore: Springer, Springer Netherlands, 2012
ISBN 10: 9401046212 ISBN 13: 9789401046213
EUR 59,97
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.
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The Timing of Toxicological Studies to Support Clinical Trials
Da: Ria Christie Collections, Uxbridge, Regno Unito
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The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop)
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Timing of Toxicological Studies to Support Clinical Trials
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Timing of Toxicological Studies to Support Clinical Trials
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