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 |  | 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 | doi | https://doi.org/10.1007/978-1-4419-6418-2 | isbn_softcover | 978-1-4939-0091-6 | isbn_ebook | 978-1-4419-6418-2 | copyright | Springer Science+Business Media, LLC 2010 |
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