BIOSIMILARS
ebook

BIOSIMILARS (ebook)

SHEIN-CHUNG CHOW

$1,800.00
IVA incluido
Editorial:
CHAPMAN & HALL
Materia
MEDICINA GRAL
ISBN:
9781040189108
Formato:
Epublication content package
Idioma:
Inglés
DRM
Si

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

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    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...

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  • ANALYTICAL SIMILARITY ASSESSMENT IN BIOSIMILAR PRODUCT DEVELOPMENT
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    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...

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  • ENCYCLOPEDIA OF BIOPHARMACEUTICAL STATISTICS - FOUR VOLUME SET
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    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...

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    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...

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  • CONTROVERSIAL STATISTICAL ISSUES IN CLINICAL TRIALS
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    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 ...

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