Dose Finding Drug Development (35 results)
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Series: Statistics for Biology and Health, Book 18 of 69. Book 18 of 69 - Statistics for Biology and Health
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Series: Statistics for Biology and Health, Book 18 of 69. Book 18 of 69 - Statistics for Biology and Health
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Condition: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions.
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Published by SP SPRINGER, 2006
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Language: English
Published by Springer, 2006
Series: Statistics for Biology and Health, Book 18 of 69. Book 18 of 69 - Statistics for Biology and Health
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Language: English
Published by Springer, 2006
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Taschenbuch. Condition: Neu. Dose Finding in Drug Development | Naitee Ting | Taschenbuch | Statistics for Biology and Health | xiv | Englisch | 2010 | Springer | EAN 9781441921154 | 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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Taschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book emphasizes dose selection issues from a statistical point of view. It presentsstatisticalapplicationsinthedesignandanalysisofdose-responsestudies. The importance of this subject can be found from the International Conference on Harmonizat…ion (ICH) E4 Guidance document. Establishing the dose-response relationship is one of the most important act- ities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases - namely Phases I, II, III, and IV. Phase I clinical trials are designed to study the clinical pharmacology. Information - tained from these studies will help in designing Phase II studies. Dose-response relationshipsareusuallystudiedinPhaseII.PhaseIIIclinicaltrialsarelarge-scale, long-term studies. These studies serve to con rm ndings from Phases I and II. ResultsobtainedfromPhasesI,II,andIIIclinicaltrialswouldthenbedocumented and submitted to regulatory agencies for drug approval. In the United States, - viewers from Food and Drug Administration (FDA) review these documents and make a decision to approve or to reject this New Drug Application (NDA). If the new drug is approved, then Phase IV studies can be started. Phase IV clinical trials are also known as postmarketing studies.
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Published by Springer, 2006
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Published by Springer, 2006
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Introduces the drug development process, the design and analysis of clinical trialsPresents statistical applications in the design and analysis of dose response studiesExamines important procedural steps from a pharma…ceutical industry persp.
