Búsqueda de LIBROS DEL AUTOR: shein chung chow

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  • INNOVATIVE METHODS FOR RARE DISEASE DRUG DEVELOPMENT
    ebook
    INNOVATIVE METHODS FOR RARE DISEASE DRUG DEVELOPMENT
    SHEIN-CHUNG CHOW
    In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this cas...

    $1,360.00

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  • INNOVATIVE STATISTICS IN REGULATORY SCIENCE
    ebook
    INNOVATIVE STATISTICS IN REGULATORY SCIENCE
    SHEIN-CHUNG CHOW
    Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical produ...

    $1,380.00

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  • ANALYTICAL SIMILARITY ASSESSMENT IN BIOSIMILAR PRODUCT DEVELOPMENT
    ebook
    ANALYTICAL SIMILARITY ASSESSMENT IN BIOSIMILAR PRODUCT DEVELOPMENT
    SHEIN-CHUNG CHOW
    This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models...

    $1,480.00

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  • ENCYCLOPEDIA OF BIOPHARMACEUTICAL STATISTICS - FOUR VOLUME SET
    ebook
    ENCYCLOPEDIA OF BIOPHARMACEUTICAL STATISTICS - FOUR VOLUME SET
    SHEIN-CHUNG CHOW
    Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requi...

    $30,000.00

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  • ADVANCED LINEAR MODELS
    ebook
    ADVANCED LINEAR MODELS
    SHEIN-CHUNG CHOW / SONG-GUI WANG
    This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction. The authors discuss the application of statistical theories and methodologies to various linear models such as the linear regression model, the analysis of variance model, the analysis of covariance model, and the variance compon...

    $4,000.00

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  • SAMPLE SIZE CALCULATIONS IN CLINICAL RESEARCH
    ebook
    SAMPLE SIZE CALCULATIONS IN CLINICAL RESEARCH
    SHEIN-CHUNG CHOW / JUN SHAO / HANSHENG WANG / YULIYA LOKHNYGINA
    Praise for the Second Edition: "… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for q...

    $1,200.00

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  • CONTROVERSIAL STATISTICAL ISSUES IN CLINICAL TRIALS
    ebook
    CONTROVERSIAL STATISTICAL ISSUES IN CLINICAL TRIALS
    SHEIN-CHUNG CHOW
    In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov ...

    $1,360.00

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  • QUANTITATIVE METHODS FOR TRADITIONAL CHINESE MEDICINE DEVELOPMENT
    ebook
    QUANTITATIVE METHODS FOR TRADITIONAL CHINESE MEDICINE DEVELOPMENT
    SHEIN-CHUNG CHOW
    In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted t...

    $1,800.00

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  • DESIGN AND ANALYSIS OF CLINICAL TRIALS
    ebook
    DESIGN AND ANALYSIS OF CLINICAL TRIALS
    SHEIN-CHUNG CHOW / JEN-PEI LIU
    Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and in...

    $1,903.00

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  • DESIGN AND ANALYSIS OF CLINICAL TRIALS
    ebook
    DESIGN AND ANALYSIS OF CLINICAL TRIALS
    SHEIN-CHUNG CHOW
    Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and in...

    $1,903.00

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  • BIOSIMILARS
    ebook
    BIOSIMILARS
    SHEIN-CHUNG CHOW
    As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf ...

    $1,800.00

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  • ADAPTIVE DESIGN METHODS IN CLINICAL TRIALS
    ebook
    ADAPTIVE DESIGN METHODS IN CLINICAL TRIALS
    SHEIN-CHUNG CHOW / MARK CHANG
    With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini ...

    $1,320.00

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  • DESIGN AND ANALYSIS OF BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
    ebook
    DESIGN AND ANALYSIS OF BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
    SHEIN-CHUNG CHOW / JEN-PEI LIU
    Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva ...

    $1,320.00

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  • STATISTICAL DESIGN AND ANALYSIS OF STABILITY STUDIES
    ebook
    STATISTICAL DESIGN AND ANALYSIS OF STABILITY STUDIES
    SHEIN-CHUNG CHOW
    The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta ...

    $1,360.00

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  • DESIGN AND ANALYSIS OF ANIMAL STUDIES IN PHARMACEUTICAL DEVELOPMENT
    ebook
    DESIGN AND ANALYSIS OF ANIMAL STUDIES IN PHARMACEUTICAL DEVELOPMENT
    SHEIN-CHUNG CHOW
    "Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examp ...

    $1,360.00

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