Interface between Regulation and Statistics in Drug Development
暫譯: 藥物開發中的法規與統計介面

Alemayehu, Demissie, Emir, Birol, Gaffney, Michael

Interface between Regulation and Statistics in Drug Development
  • 出版商: CRC
  • 出版日期: 2020-11-12
  • 售價: $5,550
  • 貴賓價: 9.5 折 $5,273
  • 語言: 英文
  • 頁數: 172
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 036749048X
  • ISBN-13: 9780367490485
  • 相關分類: 機率統計學 Probability-and-statistics

    • 海外代購書籍(需單獨結帳)

相關主題

商品描述

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs.

Features:

  • Regulatory and statistical interactions throughout the drug development continuum

  • The critical role of the statistician in relation to the changing regulatory and healthcare landscapes

  • Statistical issues that commonly arise in the course of drug development and regulatory interactions

  • Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities

The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

商品描述(中文翻譯)

統計在臨床試驗或觀察性研究的設計、執行、分析和報告中扮演著關鍵角色，這些研究旨在滿足監管需求，因此全球各地的監管機構已發布了許多針對藥物開發相關統計問題的指導方針。然而，關於這一重要主題的可用文獻零散，且往往不易為藥物開發者或監管人員所獲得。本書系統地闡述了這兩個學科之間的相互作用，包括與加速藥物開發以滿足患者未滿足需求相關的新興主題。

特色：
- 藥物開發全過程中的監管與統計互動
- 統計學家在不斷變化的監管和醫療保健環境中的關鍵角色
- 在藥物開發和監管互動過程中常見的統計問題
- 藥物開發中的趨勢主題，強調當前的監管思維及其相關挑戰和機會

本書旨在讓具備中級統計知識的讀者能夠輕鬆理解，並可作為藥物開發中統計學家、醫學研究人員和監管人員的有用資源，以及健康科學研究生的參考資料。作者在製藥行業和學術界的數十年經驗，以及豐富的監管經驗，通過書中的許多例子得以體現。

作者簡介

Demissie Alemayehu, PhD, is Vice President and Head of the Statistical Research and Data Science Center at Pfizer Inc. He is a Fellow of the American Statistical Association, has published widely, and has served on the editorial boards of major journals, including the "Journal of the American Statistical Association" and the "Journal of Nonparametric Statistics." Additionally, he has been on the faculties of both Columbia University and Western Michigan University. He has co-authored a monograph entitled, "Patient-Reported Outcomes: Measurement, Implementation and Interpretation," and co-edited another, "Statistical Topics in Health Economics and Outcome Research" both published by Chapman & Hall/CRC Press.

Birol Emir, PhD, is Senior Director and Statistics Lead of Real-World Evidence (RWE) at Pfizer Inc. In addition, Dr. Emir has served as Adjunct Professor of Statistics and Lecturer at Columbia University in New York and as an External PhD Committee Member, Graduate School of Arts and Sciences, Rutgers, The State University of New Jersey. Recently, his primary focuses have been on big data, predictive modelling and genomic data analysis. He has numerous publications in refereed journals, and he has co-edited "Statistical Topics in Health Economics and Outcome Research" published by Chapman & Hall/CRC Press. He has taught many short courses and has given several invited presentations.

Michael Gaffney, PhD, is Vice President, Statistics at Pfizer, and received his Ph.D. from New York University School of Environmental Medicine with his dissertation in the area of multistage model of cancer induction. Dr. Gaffney has spent his 43-year career in pharmaceutical research concentrating in the areas of design and analysis of clinical trials and regulatory interaction for drug approval and product defense. He has interacted with FDA, EMA, MHRA and regulators in Canada and Japan on over 25 distinct regulatory approvals and product issues in many therapeutic areas. Dr. Gaffney has published 40 peer-reviewed articles and presented at numerous scientific meetings in diverse areas of modelling cancer induction, variance components, harmonic regression, factor analysis, propensity scores, meta-analysis, large safety trials and sample size re-estimation. Dr. Gaffney was recently a member of the Council for International Organizations of Medical Sciences (CIOMS) X committee and was a co-author of, CIOMS X: Evidence Synthesis and Meta-Analysis for Drug Safety.

作者簡介(中文翻譯)

德米西·阿萊馬耶胡 (Demissie Alemayehu), PhD，是輝瑞公司 (Pfizer Inc.) 的副總裁及統計研究與數據科學中心負責人。他是美國統計協會 (American Statistical Association) 的會士，發表了大量的研究成果，並曾擔任多本主要期刊的編輯委員會成員，包括《美國統計協會期刊 (Journal of the American Statistical Association)》和《非參數統計期刊 (Journal of Nonparametric Statistics)》。此外，他曾在哥倫比亞大學 (Columbia University) 和西密西根大學 (Western Michigan University) 擔任教職。他共同撰寫了一本專著《病人報告結果：測量、實施與解釋 (Patient-Reported Outcomes: Measurement, Implementation and Interpretation)》，並共同編輯了另一本書《健康經濟學與結果研究中的統計主題 (Statistical Topics in Health Economics and Outcome Research)》，這兩本書均由查普曼與霍爾/CRC出版社 (Chapman & Hall/CRC Press) 出版。

比羅爾·埃米爾 (Birol Emir), PhD，是輝瑞公司 (Pfizer Inc.) 的高級總監及實際證據 (Real-World Evidence, RWE) 的統計負責人。此外，埃米爾博士曾擔任紐約哥倫比亞大學 (Columbia University) 的統計學兼任教授及講師，並擔任新澤西州羅格斯大學 (Rutgers, The State University of New Jersey) 藝術與科學研究所的外部博士委員會成員。最近，他的主要研究重點是大數據、預測建模和基因組數據分析。他在同行評審的期刊上發表了多篇論文，並共同編輯了由查普曼與霍爾/CRC出版社 (Chapman & Hall/CRC Press) 出版的《健康經濟學與結果研究中的統計主題 (Statistical Topics in Health Economics and Outcome Research)》。他教授了多個短期課程並進行了多次受邀演講。

邁克爾·加夫尼 (Michael Gaffney), PhD，是輝瑞 (Pfizer) 的副總裁，負責統計學，並在紐約大學環境醫學院 (New York University School of Environmental Medicine) 獲得博士學位，論文研究癌症誘導的多階段模型。加夫尼博士在製藥研究領域擁有43年的職業生涯，專注於臨床試驗的設計與分析以及藥物批准和產品防禦的監管互動。他與FDA、EMA、MHRA以及加拿大和日本的監管機構就超過25個不同的監管批准和產品問題進行了互動，涵蓋多個治療領域。加夫尼博士已發表40篇同行評審的文章，並在多個科學會議上就癌症誘導建模、變異成分、諧波回歸、因子分析、傾向分數、元分析、大型安全試驗和樣本大小重新估算等多個領域進行了報告。加夫尼博士最近是國際醫學科學組織理事會 (Council for International Organizations of Medical Sciences, CIOMS) X 委員會的成員，並共同撰寫了《CIOMS X：藥物安全的證據綜合與元分析 (CIOMS X: Evidence Synthesis and Meta-Analysis for Drug Safety)》。

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