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[生物书合集].Advances.in.Clinical.TBiostatisti

[生物书合集].Advances.in.Clinical.TBiostatisti

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Series Introduction The primary objectives of the Biostatistics series are to provide useful ref- erence books for researchers and scientists in academia, industry, and government, and also to offer textbooks for undergraduate and/or grad- uate courses in the area of biostatistics. The series provides comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics, such as those in biopharmaceuticals. A well- balanced summary is given of current and recently developed statistical methods and interpretations for both statisticians and researchers/scien- tists with minimal statistical knowledge who are engaged in the field of applied biostatistics. The series is committed to presenting easy-to-under- stand, state-of-the-art references and textbooks. In each volume, statistical
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Unformatted text preview: concepts and methodologies are illustrated through real-world examples whenever possible. Clinical research is a lengthy and costly process that involves drug discovery, formulation, laboratory development, animal studies, clinical development, and regulatory submission. This lengthy process is necessary not only for understanding the target disease but also for providing sub-stantial evidence regarding efficacy and safety of the pharmaceutical com-pound under investigation prior to regulatory approval. In addition, it provides assurance that the drug products under investigation will possess good characteristics such as identity, strength, quality, purity, and stability after regulatory approval. For this purpose, biostatistics plays an impor-Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved....
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