Predictive Subgroup/Biomarker Identification and Machine Learning Methods.- Characterize and Dichotomize a Continuous Biomarker.- Surrogate Biomarkers.- Innovative Designs for Biomarker Guided Trials.- Statistical Considerations in the Development of Companion Diagnostic Device.- Biomarker Assay Development, Qualification and Validation.- Validation of Genomic Based Assay.- Clinical Application of Molecular Features in Therapeutic Selection and Drug Development.- Big data, real-world data, and machine learning.- Design and Analysis of Clinical Pharmacology Studies.- Statistical Considerations in Proof of Concept Studies.- Safety in Early Phase Studies.- Statistical Evaluation of QT/QTc Interval Prolongation.- Phase II Dose Finding.- Pharmacometrics.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Liang Fang is an Executive Director and Head of Biostatistics in MyoKardia Inc. His research interests include statistical applications in drug development, precision medicine, and digital health.
Cheng Su is an Executive Director of Data Science & Analytics at BioMarin, Inc. His research interests include statistical applications and tool development in drug discovery, biomarkers, clinical trials design, risk based monitoring, mobile health and big data.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Taschenbuch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference.Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource.This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials. 360 pp. Englisch. N° de réf. du vendeur 9783030315054
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Kartoniert / Broschiert. Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Presents statistical methods in early clinical drug and biomarker development in one convenient volumeIncludes chapters written by experts in the pharmaceutical industryEmphasizes practical applicatio. N° de réf. du vendeur 448678744
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