Statistical Methods in Biomarker and Early Clinical Development

• Corporate Author: SpringerLink (Online service)
• Other Authors: Fang, Liang (Editor, http://id.loc.gov/vocabulary/relators/edt), Su, Cheng (Editor, http://id.loc.gov/vocabulary/relators/edt)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Edition: 1st ed. 2019.
• Subjects: Statistics .; Biomathematics.; Biostatistics.; Statistics for Life Sciences, Medicine, Health Sciences.; Physiological, Cellular and Medical Topics.

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 oft...

Table of Contents:

• 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.