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Titlebook: Dose Finding in Drug Development; Naitee Ting Book 2006 Springer-Verlag New York 2006 Maxima.Radiologieinformationssystem.clinical trial.c

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發(fā)表于 2025-3-21 16:38:32 | 只看該作者 |倒序?yàn)g覽 |閱讀模式
書目名稱Dose Finding in Drug Development
編輯Naitee Ting
視頻videohttp://file.papertrans.cn/283/282677/282677.mp4
概述Introduces the drug development process, the design and analysis of clinical trials.Presents statistical applications in the design and analysis of dose response studies.Examines important procedural
叢書名稱Statistics for Biology and Health
圖書封面Titlebook: Dose Finding in Drug Development;  Naitee Ting Book 2006 Springer-Verlag New York 2006 Maxima.Radiologieinformationssystem.clinical trial.c
描述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 Harmonization (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 start
出版日期Book 2006
關(guān)鍵詞Maxima; Radiologieinformationssystem; clinical trial; computerassistierte Detektion; development; drug; dr
版次1
doihttps://doi.org/10.1007/0-387-33706-7
isbn_softcover978-1-4419-2115-4
isbn_ebook978-0-387-33706-7Series ISSN 1431-8776 Series E-ISSN 2197-5671
issn_series 1431-8776
copyrightSpringer-Verlag New York 2006
The information of publication is updating

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1431-8776 iewers 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 start978-1-4419-2115-4978-0-387-33706-7Series ISSN 1431-8776 Series E-ISSN 2197-5671
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地板
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Ultrasonography in Ophthalmology XVThe . . model is a nonlinear model frequently used in dose–response analyses. The model is shown in Eq. (9.1)
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,Analysis of Dose–Response Studies—Emax Model,The . . model is a nonlinear model frequently used in dose–response analyses. The model is shown in Eq. (9.1)
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Introduction and New Drug Development Process,the intended disease condition) and safe (with acceptable risk of adverse effects). If such a dose range cannot be identified, the candidate would not be a medically useful or commercially viable pharmaceutical product, nor should it be approved by regulatory agencies.
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Boolean Algebras and Propositional Calculusthe intended disease condition) and safe (with acceptable risk of adverse effects). If such a dose range cannot be identified, the candidate would not be a medically useful or commercially viable pharmaceutical product, nor should it be approved by regulatory agencies.
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發(fā)表于 2025-3-23 06:41:52 | 只看該作者
https://doi.org/10.1007/978-94-011-5040-8ied from a cell culture or from a modified animal or egg. There is often some biological theory that supports the creation of this candidate. It might be based upon inserting a specific human gene into the DNA of the culture, or some specific configuration of the small molecule that is designed to “
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