Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development

Fang, Liang; Su, Cheng

Springer Nature Switzerland AG






15 a 20 dias


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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.
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Biomarkers;Biomarker testing;Biomarker Development;Biomarker data;Biomarker book;Early clinical development;Predictive biomarker;Drug development statistics;Biostatistics;Personalized Medicine;Precision Medicine;Translational Medicine;Clinical Trials;Pharmaceutical Development;Machine learning medicine;Clinical pharmacology;Clinical pharmacology in drug development;Pharmacodynamics