Statistical Methods in Biomarker and Early Clinical Development

Buch | Softcover

XII, 348 Seiten

2021 | 1st ed. 2019
Springer International Publishing (Verlag)
978-3-030-31505-4 (ISBN)

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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.

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.

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.

Erscheinungsdatum	10.01.2021
Zusatzinfo	XII, 348 p. 54 illus., 31 illus. in color.
Verlagsort	Cham
Sprache	englisch
Maße	155 x 235 mm
Gewicht	551 g
Themenwelt	Informatik ► Weitere Themen ► Bioinformatik
	Mathematik / Informatik ► Mathematik ► Statistik
	Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
	Medizin / Pharmazie
Schlagworte	Biomarker book • Biomarker data • Biomarker development • Biomarkers • Biomarker testing • Biostatistics • Clinical Pharmacology • Clinical pharmacology in drug development • Clinical Trials • Drug development statistics • Early clinical development • Machine learning medicine • Personalized medicine • Pharmaceutical development • Pharmacodynamics • Precision medicine • Predictive biomarker • Translational Medicine
ISBN-10	3-030-31505-3 / 3030315053
ISBN-13	978-3-030-31505-4 / 9783030315054
Zustand	Neuware