Analytical Similarity Assessment in Biosimilar Product Development
暫譯: 生物相似產品開發中的分析相似性評估

Chow, Shein-Chung

Analytical Similarity Assessment in Biosimilar Product Development
  • 出版商: CRC
  • 出版日期: 2020-12-18
  • 售價: $2,560
  • 貴賓價: 9.5 折 $2,432
  • 語言: 英文
  • 頁數: 354
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367733838
  • ISBN-13: 9780367733834

    • 海外代購書籍(需單獨結帳)

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商品描述

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/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.





商品描述(中文翻譯)

本書專注於生物相似產品開發中的分析相似性評估，遵循FDA建議的逐步方法，以獲得生物相似產品批准的整體證據。內容涵蓋了在生物相似產品製造過程中，對關鍵品質屬性相似性評估的分層方法、用於關鍵品質屬性分類的統計模型/方法、Tier 1中關鍵品質屬性的等效性測試及相應的樣本大小要求、當前問題以及分析相似性評估的最新發展。

作者簡介



Author



Shein-Chung Chow, Ph.D, is currently an Associate Director at Office of



Biostatistics, Center for Drug Evaluation and Research, United States Food



and Drug Administration (FDA). Prior to joining FDA, Dr. Chow was a



Professor at Duke University School of Medicine, Durham, NC. He was



also a special government employee (SGE) appointed by the FDA as an



Advisory Committee member and statistical advisor to the FDA. Prior to



that, Dr. Chow also held various positions in the pharmaceutical industry



such as Vice President at Millennium, Cambridge, MA, Executive Director at



Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers



Squibb, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of



Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series



at Chapman and Hall/CRC Press, Taylor & Francis Group. He was elected



Fellow of the American Statistical Association and an elected member of the



ISI (International Statistical Institute). Dr. Chow is the author or co-author of



over 300 methodology papers and 29 books including Designs and Analysis



of Bioavailability and Bioequivalence Studies, Sample Size Calculations in Clinical



Research, Adaptive Design Methods in Clinical Trials, Translational Medicine,



Design and Analysis of Clinical Trials, and Quantitative Methods for Traditional



Chinese Medicine Development.

作者簡介(中文翻譯)



作者



周賢忠博士（Shein-Chung Chow, Ph.D）目前擔任美國食品藥品監督管理局（FDA）藥物評估與研究中心生物統計辦公室的副主任。



在加入FDA之前，周博士曾是杜克大學醫學院（Duke University School of Medicine, Durham, NC）的教授。他還曾擔任FDA的特別政府雇員（SGE），作為諮詢委員會成員及統計顧問。在此之前，周博士在製藥行業擔任過多個職位，包括麻州劍橋的千禧公司（Millennium）副總裁、新澤西州普林斯頓的Covance執行董事，以及新澤西州普蘭斯伯勒的百時美施貴寶（Bristol-Myers Squibb）董事及部門主管。周博士是生物製藥統計期刊（Journal of Biopharmaceutical Statistics）的主編，以及Chapman and Hall/CRC Press, Taylor & Francis Group的生物統計書系列（Biostatistics Book Series）的主編。他被選為美國統計協會（American Statistical Association）會士，並且是國際統計學會（ISI, International Statistical Institute）的當選成員。周博士是超過300篇方法論論文和29本書籍的作者或合著者，包括生物可用性和生物等效性研究的設計與分析（Designs and Analysis of Bioavailability and Bioequivalence Studies）、臨床研究中的樣本大小計算（Sample Size Calculations in Clinical Research）、臨床試驗中的自適應設計方法（Adaptive Design Methods in Clinical Trials）、轉化醫學（Translational Medicine）、臨床試驗的設計與分析（Design and Analysis of Clinical Trials）以及傳統中醫發展的定量方法（Quantitative Methods for Traditional Chinese Medicine Development）。

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