Get Statistical Methods for Immunogenicity Assessment (Chapman & PDF

By Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao

ISBN-10: 1498700349

ISBN-13: 9781498700344

Immunogenicity evaluation is a prerequisite for the winning improvement of biopharmaceuticals, together with security and efficacy review. utilizing complicated statistical tools within the examine layout and research phases is for this reason necessary to immunogenicity threat evaluation and mitigation concepts. Statistical equipment for Immunogenicity evaluation offers a unmarried resource of data on statistical recommendations, rules, tools, and techniques for detection, quantification, review, and keep watch over of immunogenicity.

The e-book first offers an outline of the influence of immunogenicity on biopharmaceutical improvement, regulatory standards, and statistical tools and techniques used for immunogenicity detection, quantification, and chance evaluation and mitigation. It then covers anti-drug antibody (ADA) assay improvement, optimization, validation, and move in addition to the research of minimize element, a key assay functionality parameter in ADA assay improvement and validation. The authors illustrate how you can practice statistical modeling techniques to set up institutions among ADA and medical results, expect immunogenicity threat, and improve chance mitigation innovations. additionally they current quite a few thoughts for immunogenicity threat keep watch over. The publication concludes with an evidence of the pc codes and algorithms of the statistical methods.

A serious factor within the improvement of biologics, immunogenicity may cause early termination or constrained use of the goods if now not controlled good. This booklet exhibits the best way to use strong statistical equipment for detecting, quantifying, assessing, and mitigating immunogenicity danger. it really is a useful source for somebody excited about immunogenicity threat evaluation and keep an eye on in either non-clinical and medical biopharmaceutical improvement.

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Additional resources for Statistical Methods for Immunogenicity Assessment (Chapman & Hall/CRC Biostatistics Series)

Sample text

4 Precision . . . . . . . . . . . . . . . . . . . 5 Robustness . . . . . . . . . . . . . . . . . . 6 Ruggedness/Reproducibility . . . . . . . . . 2 Life-Cycle Approach . . . . . . . . . . . . . . . . . . . Design of Experiment . . . . . . . . . . . . . . . . . . . . . . 1 Fractional Factorial Design . . . . . . . . . . . . . . . 2 Response Surface Design . . . . . . . . . . .

5 Robustness . . . . . . . . . . . . . . . . . . 6 Ruggedness/Reproducibility . . . . . . . . . 2 Life-Cycle Approach . . . . . . . . . . . . . . . . . . . Design of Experiment . . . . . . . . . . . . . . . . . . . . . . 1 Fractional Factorial Design . . . . . . . . . . . . . . . 2 Response Surface Design . . . . . . . . . . . . . . . . 3 Split-Plot Design . . . . . . . . . .

Method Transfer . . . . . . . . . . . . . . . . . . . . . . . . . 3 23 24 25 25 26 26 28 29 29 29 33 33 35 35 35 36 38 41 43 46 48 48 The assessment of immunogenicity depends on appropriate detection, quantification, and characterization of ADAs. However, there are multiple challenges for successfully developing ADA assays. Unlike biological assays for measuring drug concentration or protein concentration in human serum, concentrations of ADAs are very low and often in magnitude of ng/mL.

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Statistical Methods for Immunogenicity Assessment (Chapman & Hall/CRC Biostatistics Series) by Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao


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