Mcauslane (70 results)
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Condition: Good. *Price HAS BEEN REDUCED by 10% until Monday, July 13 (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 duti…es, taxes, or fees required by recipient's country.
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Cloth/Laminated Boards. Condition: Very Good. Dust Jacket Condition: No d/j as Published. 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 re…gulatory 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.
- Hardcover
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Cloth/Laminated Boards. Condition: Very Good. Dust Jacket Condition: No d/j as Published. 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 t…heir 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.
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
Walker, S. R. (EDT); Lumley, Cynthia (EDT); Mcauslane, N. (EDT)
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- Softcover
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Paperback or Softback. Condition: New. Improving the Regulatory Review Process: Assessing Performance and Setting Targets. Book.
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Paperback or Softback. Condition: 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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- Softcover
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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
Walker, S. R. (EDT); Lumley, Cynthia (EDT); Mcauslane, N. (EDT)
- Softcover
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- Softcover
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Condition: New. pp. xix + 163.
- Softcover
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- Softcover
Seller: moluna, Greven, Germanymoluna
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Condition: New. KlappentextrnrnThis scarce antiquarian book is a facsimile reprint of the original. Due to its age, it may contain imperfections such as marks, notations, marginalia and flawed pages. Because we believe this work is culturally important, we have.
- Softcover
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Paperback. Condition: Brand New. 1997 edition. 163 pages. 9.45x6.30x0.43 inches. In Stock.
- Hardcover
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- Softcover
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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Taschenbuch. Condition: Neu. Neuware - This scarce antiquarian book is a facsimile reprint of the original. Due to its age, it may contain imperfections such as marks, notations, marginalia and flawed pages. Because we believe this work is culturally important, we have made it available as part of our commitment for protecting,…preserving, and promoting the world's literature in affordable, high quality, modern editions that are true to the original work.
- Hardcover
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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- Hardcover
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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- Softcover
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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Taschenbuch. Condition: 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.
Timing of Toxicological Studies to Support Clinical Trials
Parkinson, Christopher (EDT); McAuslane, Neil (EDT); Lumley, Cyndy (EDT); Walker, Stuart (EDT)
- Hardcover
Seller: GreatBookPrices, Columbia, MD, U.S.A.GreatBookPrices
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- Softcover
Seller: preigu, Osnabrück, Germanypreigu
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Taschenbuch. Condition: 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 H…eidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
- Softcover
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
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Taschenbuch. Condition: 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 p…ossible 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.
Timing of Toxicological Studies to Support Clinical Trials
Parkinson, C. (EDT); Mcauslane, N. (EDT); Lumley, Cynthia (EDT); Walker, S. R. (EDT)
- Softcover
Seller: GreatBookPrices, Columbia, MD, U.S.A.GreatBookPrices
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- Softcover
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
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