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Titlebook: New Drug Development; An Introduction to C J. Rick Turner Book 2010Latest edition Springer Science+Business Media, LLC 2010 Clinical.Develo

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发表于 2025-3-21 17:15:59 | 显示全部楼层 |阅读模式
书目名称New Drug Development
副标题An Introduction to C
编辑J. Rick Turner
视频video
概述Discuss the latest developments in the realm of drug safety, and expands its coverage of clinical trials considerably Provides a conceptual introduction to statistics and illustrates its important rol
图书封面Titlebook: New Drug Development; An Introduction to C J. Rick Turner Book 2010Latest edition Springer Science+Business Media, LLC 2010 Clinical.Develo
描述New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, ‘Design, Methodology, and Analysis‘. Optimum quality study design and experimental research methodology must b
出版日期Book 2010Latest edition
关键词Clinical; Development; Drug; Introduction; Trial; Turner; methodology
版次2
doihttps://doi.org/10.1007/978-1-4419-6418-2
isbn_softcover978-1-4939-0091-6
isbn_ebook978-1-4419-6418-2
copyrightSpringer Science+Business Media, LLC 2010
The information of publication is updating

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New Drug Development,novel chemical compound, i.e., a new chemical entity (NCE) or new molecular entity (NME), as its active ingredient. In the case of biologicals, attention focuses on proteins that are produced via the large-scale cultivation of microbial or mammalian cells.
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Sample Size Estimation, an understanding of important concepts, including statistical significance and clinical significance, before reading about sample size estimation. Addressing sample size estimation at this point also allows a whole (short) chapter to be dedicated to this topic, thereby acknowledging its importance in clinical research.
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Cardiac and Cardiovascular Safety Assessments,ng). In this chapter discussions focus on analogous evaluations in humans if a sponsor decides to move the drug molecule into clinical trials. At this point, the term investigational drug can be adopted.
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General Safety Assessments,cussions of safety now move to safety assessments in clinical trials. This chapter discusses general safety assessments, and Chapter 14 addresses specialized cardiac and cardiovascular safety assessments that have recently become critical components of new drug development. Postmarketing surveillance is discussed later in Chapter 16.
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Manufacturing Small Molecule Drugs and Biologicals,l. Successfully producing the drug candidate for nonclinical testing and clinical trials and manufacturing the drug for postapproval marketing are critical. Moreover, their complexity and difficulty should not be underestimated.
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