Statistical Methods for Immunogenicity Assessment
暫譯: 免疫原性評估的統計方法

Yang, Harry, Zhang, Jianchun, Yu, Binbing

  • 出版商: CRC
  • 出版日期: 2020-12-18
  • 售價: $2,480
  • 貴賓價: 9.5$2,356
  • 語言: 英文
  • 頁數: 259
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367737973
  • ISBN-13: 9780367737979
  • 海外代購書籍(需單獨結帳)

商品描述

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.

商品描述(中文翻譯)

發展有效的免疫原性風險緩解策略





免疫原性評估是生物製藥成功開發的前提,包括安全性和有效性評估。因此,在研究設計和分析階段使用先進的統計方法對於免疫原性風險評估和緩解策略至關重要。免疫原性評估的統計方法提供了有關統計概念、原則、方法和策略的單一信息來源,這些方法和策略用於檢測、量化、評估和控制免疫原性。





本書首先概述了免疫原性對生物製藥開發的影響、法規要求以及用於免疫原性檢測、量化和風險評估與緩解的統計方法和策略。接著,書中涵蓋了抗藥物抗體(ADA)檢測的開發、優化、驗證和轉移,以及切點分析,這是ADA檢測開發和驗證中的一個關鍵檢測性能參數。作者說明了如何應用統計建模方法來建立ADA與臨床結果之間的關聯,預測免疫原性風險,並發展風險緩解策略。他們還提出了各種免疫原性風險控制策略。本書最後解釋了統計方法的計算機代碼和算法。





免疫原性是生物製劑開發中的一個關鍵問題,如果管理不當,可能導致產品的早期終止或使用受限。本書展示了如何使用穩健的統計方法來檢測、量化、評估和緩解免疫原性風險。這是一本對於參與非臨床和臨床生物製藥開發中免疫原性風險評估和控制的任何人來說都非常寶貴的資源。

作者簡介

Harry Yang is a senior director, Jianchun Zhang is a principal statistician, Binbing Yu is an associate director, and Wei Zhao is a senior principal statistician at MedImmune, LLC in Gaithersburg, Maryland, USA.

作者簡介(中文翻譯)

Harry Yang 是美國馬里蘭州蓋瑟斯堡的 MedImmune, LLC 的高級總監,Jianchun Zhang 是首席統計學家,Binbing Yu 是副總監,Wei Zhao 是高級首席統計學家。