Statistical Methods for Immunogenicity Assessment by Harry Yang
Develop Effective Immunogenicity Risk Mitigation Strategies
Immunogenicity 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 strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity.
The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods.
A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.
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R for Health Technology Assessment
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Value of Information for Healthcare Decision-Making
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Bayesian Models in Health Technology Assessment
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Randomization, Masking, and Allocation Concealment
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Exposure-Response Modeling
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Mixture Modelling for Medical and Health Sciences
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Data Analysis with Competing Risks and Intermediate States
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Statistics In the Pharmaceutical Industry
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Design and Analysis of Bioavailability and Bioequivalence Studies
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Mixed Effects Models for the Population Approach
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Multiple Testing Problems in Pharmaceutical Statistics
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Machine Learning for Microbiome Statistics
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Master Protocol Clinical Trials for Evidence Generation
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Does This Treatment Cause That Outcome?
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Comparative Effectiveness and Personalized Medicine Research Using Real-World Data
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Age-Period-Cohort Models
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Biostatistics for Bioassay
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Statistical Methods for Survival Trial Design
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Every Coin Has Two Sides
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Group Sequential and Adaptive Methods for Clinical Trials
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Empirical Likelihood Method in Survival Analysis
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Multiregional Clinical Trials for Simultaneous Global New Drug Development
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Adaptive Design Methods in Clinical Trials
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Clinical Trial Data Analysis Using R and SAS
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Bayesian Cost-Effectiveness Analysis of Medical Treatments
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Statistical Methods for Drug Safety
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Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
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Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement
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Meta-Analysis in Medicine and Health Policy
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Model-Assisted Bayesian Designs for Dose Finding and Optimization
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Statistical Methods in Drug Combination Studies
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Design and Analysis of Clinical Trials for Predictive Medicine
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Frailty Models in Survival Analysis
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Bayesian Methods in Health Economics
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Survival Analysis in Medicine and Genetics
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Clinical Trial Methodology
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Applied Surrogate Endpoint Evaluation Methods with SAS and R
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Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials
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Design and Analysis of Animal Studies in Pharmaceutical Development
"In summary, this book is a good resource to the professionals and practitioners developing the biological therapies, including statisticians, clinicians, pharmacokineticists, regulatory reviewers, toxicologists, clinical assay developers, and biopharmaceutical engineers"
~Journal of Biopharmaceutical Statistics
"The authors' work brings light into some of the issues surrounding immunogenicity of drugs. It is of great help to both clinical and nonclinical professionals, while some of the concepts can also be applied to situations when an immune response towards a drug (a vaccine) is desirable."
~Paul Tudor Tamas
| SKU | Unavailable |
| ISBN 13 | 9781498700344 |
| ISBN 10 | 1498700349 |
| Title | Statistical Methods for Immunogenicity Assessment |
| Author | Harry Yang |
| Series | Chapman And Hall Crc Biostatistics Series |
| Condition | Unavailable |
| Binding Type | Hardback |
| Publisher | CRC Press LLC |
| Year published | 2015-09-03 |
| Number of pages | 259 |
| Cover note | Book picture is for illustrative purposes only, actual binding, cover or edition may vary. |
| Note | Unavailable |