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  • Clinical Trial Modernization

    Technological, Operational, and Regulatory Advances

    Collections series Chapman & Hall/CRC Biostatistics Series
    As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development. Clinical Trial Modernization: Technological, Operational, and Regulatory Advances provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing ... En savoir plus

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  • Data Science, AI, and Machine Learning in Drug Development

    Modifié par Harry Yang ...
    Collections series Chapman & Hall/CRC Biostatistics Series
    The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data ... En savoir plus

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  • Real-World Evidence in Drug Development and Evaluation

    Modifié par Harry Yang, Binbing Yu ...
    Collections series Chapman & Hall/CRC Biostatistics Series
    Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering ... En savoir plus

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  • Bayesian Analysis with R for Drug Development

    Concepts, Algorithms, and Case Studies

    Collections series Chapman & Hall/CRC Biostatistics Series
    Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development.Written specifically for ... En savoir plus

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  • Statistical Methods in Drug Combination Studies

    Modifié par Wei Zhao, Harry Yang ...
    Collections series Chapman & Hall/CRC Biostatistics Series
    The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve ... En savoir plus

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  • Statistics for Biotechnology Process Development

    Modifié par Todd Coffey, Harry Yang ...
    Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written ... En savoir plus

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  • Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

    par Harry Yang ...
    Collections series Chapman & Hall/CRC Biostatistics Series
    The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of ... En savoir plus

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  • Statistical Methods for Immunogenicity Assessment

    Collections series Chapman & Hall/CRC Biostatistics Series
    Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra ... En savoir plus

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  • Biosimilars

    Regulatory, Clinical, and Biopharmaceutical Development

    Collections Livre 34 - AAPS Advances in the Pharmaceutical Sciences Series
    This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive ... En savoir plus

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  • Clinical Trial Data Analysis Using R and SAS

    Collections series Chapman & Hall/CRC Biostatistics Series
    Review of the First Edition"The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it …The example-based approach is easy to follow and makes the book a very helpful desktop reference for many ... En savoir plus

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  • Epidemiology and Medical Statistics

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    This volume, representing a compilation of authoritative reviews on a multitude of uses of statistics in epidemiology and medical statistics written by internationally renowned experts, is addressed to statisticians working in biomedical and epidemiological fields who use statistical and quantitative methods in their work. While the use of statistics in these fields has a long and rich history, ... En savoir plus

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