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Bücher der Reihe Chapman & Hall/CRC Biostatistics Series

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  • - Current and Controversial Issues in Design and Analysis
     
    81,00 €

    This book provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. The book covers state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes.

  •  
    105,00 €

    This volume discusses the development and application of Bayesian statistical methods for the analysis of high-throughput bioinformatics data arising from problems in molecular and structural biology and disease-related medical research. It presents a broad overview of statistical inference, clustering, and classification problems in two main high-throughput platforms: microarray gene expression and phylogenic analysis. Illustrating concepts using real-world data, the book covers a variety of recently developed Bayesian techniques, along with applications in genome-wide studies, phylogenetics, breast cancer, expression genomics, and more.

  •  
    286,00 €

    Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.

  •  
    214,00 €

    Bayesian methods have emerged as the driving force for methodological development in drug development. This edited book provides broad coverage of Bayesian methods in pharmaceutical research. The book includes contributions from some of the leading researchers in the field, and has been edited to ensure consistency in level and style.

  • - Multi-Regional Clinical Trials after ICH E17
    von Bruce Binkowitz, William Wang, Hui (Sanofi-Aventis Quan & usw.
    239,00 €

    This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.

  • - Concepts, Algorithms, and Case Studies
    von Harry Yang & Steven Novick
    73,00 €

  • von Shein-Chung Chow, Feng Chen, Wei (Senior Director, usw.
    237,00 €

    This book is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development.

  • von Seattle, University Of Washington, USA) Cummings & usw.
    81,00 - 214,00 €

  • von Sang Joon Lee
    81,00 €

    Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval.Key Features:Reviews withdrawn draft guidance on analytical similarity assessment.Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines.Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability.Discusses the feasibility and validity of the non-medical switch studies.Provides innovative thinking for detection of possible reference product change over time.This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

  • von Catherine Legrand
    77,00 €

  • von USA) Peace, Karl E. (Georgia Southern University & Ding-Geng (Din) (University of North Carolina Chen
    81,00 €

  • von Binbing (MedImmune Yu & Yingwei (Department of Public Health Sciences Peng
    65,00 €

  • von Adam T. Perzynski, Douglas D. (Case Western Reserve University at MetroHealth Medical Centre) Gunzler & Adam C. Carle
    74,00 €

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