第 1/5 張圖片
DATA & SAFETY Monitoring Committees In Clinical Trials HARDCOVER Jay Herson 2nd
狀況：
“Tight binding! Pages ALL super crisp/clean/unmarked! Hardcover has just a HINT of shelf wear, ”... 閱讀更多內容關於物品狀況
庫存 2 件
運費：
所在地：Poway, California, 美國
送達日期：
估計於 6月14日, 五至 6月17日, 一之間送達 運送地點 43230
退貨：
保障：
請參閱物品說明或聯絡賣家以取得詳細資料。閱覽全部詳情查看保障詳情
（不符合「eBay 買家保障方案」資格）
物品細節
- 物品狀況
- 很新
- 賣家備註
- Book Title
- Data & Safety Monitoring Committees In Clinical Trials
- Subject
- Biostatistics, Probability & Statistics / General, Pharmacology
- Genre
- Pharmacology
- Narrative Type
- Nonfiction
- Country/Region of Manufacture
- United States
- Intended Audience
- Adults
- Ex Libris
- No
- Era
- 2010s
- Unit Quantity
- 1
- ISBN
- 9781498784108
- EAN
- 9781498784108
- Subject Area
- Mathematics, Medical
- Publication Name
- Data and Safety Monitoring Committees in Clinical Trials
- Item Length
- 9.3 in
- Publisher
- CRC Press LLC
- Publication Year
- 2016
- Series
- Chapman and Hall/Crc Biostatistics Ser.
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Item Height
- 0.7 in
- Item Width
- 6.1 in
- Item Weight
- 18.4 Oz
- Number of Pages
- 241 Pages
關於產品
Product Information
Praise for the first edition: "Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book--not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
Product Identifiers
Publisher
CRC Press LLC
ISBN-10
1498784100
ISBN-13
9781498784108
eBay Product ID (ePID)
227596031
Product Key Features
Publication Name
Data and Safety Monitoring Committees in Clinical Trials
Format
Hardcover
Language
English
Subject
Biostatistics, Probability & Statistics / General, Pharmacology
Publication Year
2016
Series
Chapman and Hall/Crc Biostatistics Ser.
Type
Textbook
Subject Area
Mathematics, Medical
Number of Pages
241 Pages
Dimensions
Item Length
9.3 in
Item Height
0.7 in
Item Width
6.1 in
Item Weight
18.4 Oz
Additional Product Features
Edition Number
2
LCCN
2016-026387
Intended Audience
College Audience
Lc Classification Number
Rm301.27.H47 2017
Edition Description
Revised Edition,New Edition
Reviews
"The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industrysponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the aspects of data safety monitoring committee (DMC) activities. A great feature of the book is the "DMCounselor" section at the end of each chapter, covering nearly 70 questions with answers, of which about 33% are for a DMC Chair, 30% for the DMC Biostatistician member, 30% for a DMC physician member, and the rest are for others (e.g., project manager)." ~ Daniel Jia, Journal of Biopharmaceutical Statistics "Nicely written and readable cover-to-cover, the author walks through every facet of a Data Monitoring Committee (DMC) beginning with an overview of their past and current place in drug development, to how they are organized and interfaced with other committees, and on to the specifics of how a typical meeting is split into an open and closed session. From there it moves on to clinical issues, including how SAEs are categorized, statistical methods, including Bayesian and frequentist conditional power calculations, common biases and pitfalls, and guidance for how DMC decisions are made. It concludes with emerging issues due to new clinical trial designs mandated by the FDA to speed up the drug development process." ~Donna Pauler Ankerst, Biometrics d session. From there it moves on to clinical issues, including how SAEs are categorized, statistical methods, including Bayesian and frequentist conditional power calculations, common biases and pitfalls, and guidance for how DMC decisions are made. It concludes with emerging issues due to new clinical trial designs mandated by the FDA to speed up the drug development process." ~Donna Pauler Ankerst, Biometrics, "The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industrysponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the aspects of data safety monitoring committee (DMC) activities. A great feature of the book is the "DMCounselor" section at the end of each chapter, covering nearly 70 questions with answers, of which about 33% are for a DMC Chair, 30% for the DMC Biostatistician member, 30% for a DMC physician member, and the rest are for others (e.g., project manager)." ~ Daniel Jia, Journal of Biopharmaceutical Statistics
Table of Content
Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.
Copyright Date
2017
Dewey Decimal
610.724
Dewey Edition
22
Illustrated
Yes
賣家提供的物品說明
運費與處理費
物品所在地：
Poway, California, 美國
運送地點
不丹, 中國, 中國台灣, 中國澳門, 中國香港, 中非共和國, 丹麥, 乍德, 也門, 亞塞拜疆共和國, 亞美尼亞, 以色列, 伯利茲, 佛得角群島, 保加利亞, 克羅地亞共和國, 冰島, 列支敦士登, 利比利亞, 剛果共和國, 剛果民主共和國, 加拿大, 加納, 加蓬共和國, 匈牙利, 南非, 南韓, 博茨瓦納, 卡塔爾, 印尼, 印度, 危地馬拉, 厄瓜多爾, 厄立特里亞, 吉布提, 吉爾吉斯, 哈薩克, 哥倫比亞, 哥斯達黎加, 喀麥隆, 土庫斯安德凱科斯群島, 土庫曼, 土耳其, 圭亞那, 坦桑尼亞, 埃及, 埃塞俄比亞, 基里巴斯, 塔吉克, 塞內加爾, 塞拉利昂, 塞浦路斯, 塞爾維亞, 塞舌爾, 墨西哥, 多哥, 多明尼加共和國, 奧地利, 孟加拉, 安哥拉, 安圭拉島, 安提瓜和巴布達, 安道爾, 寮國, 尼加拉瓜, 尼日利亞, 尼日爾, 尼泊爾, 巴哈馬, 巴基斯坦, 巴布亞新畿內亞, 巴拉圭, 巴拿馬, 巴林, 巴西, 布基納法索, 布隆迪, 希臘, 幾內亞, 幾內亞比索, 德國, 意大利, 愛沙尼亞, 愛爾蘭, 所羅門群島, 拉脫維亞, 挪威, 捷克共和國, 摩洛哥, 摩爾多瓦, 摩納哥, 斐濟, 斯威士蘭, 斯洛伐克, 斯洛文尼亞, 斯里蘭卡, 新加坡, 日本, 智利, 柬埔寨, 格陵蘭, 格雷納達, 格魯吉亞, 梵蒂岡, 比利時, 毛里求斯, 汶萊, 沙特阿拉伯, 法國, 波斯尼亞和黑塞哥維那, 波蘭, 泰國, 津巴布韋, 洪都拉斯, 海地, 湯加, 澳洲, 烏干達, 烏拉圭, 烏茲別克, 牙買加, 特里尼達和多巴哥, 玻利維亞, 瑙魯, 瑞典, 瑞士, 瓦利斯和富圖納群島, 瓦努阿圖, 甘比亞, 百慕達群島, 盧旺達, 盧森堡, 直布羅陀, 科威特, 科特迪瓦（象牙海岸）, 秘魯, 突尼斯, 立陶宛, 約旦, 納米比亞, 紐西蘭, 羅馬尼亞, 美國, 聖基茨-尼維斯, 聖文森和格瑞那丁, 聖盧西亞, 聖馬力諾, 肯亞, 芬蘭, 英國, 茅利塔尼亞, 荷蘭, 莫桑比克, 菲律賓, 萊索托, 葡萄牙, 蒙古, 蒙特色拉特島, 薩爾瓦多, 蘇里南, 西班牙, 西薩摩亞, 貝寧, 贊比亞, 赤道幾內亞, 越南, 開曼群島, 阿富汗, 阿拉伯聯合酋長國, 阿曼, 阿根廷, 阿爾及利亞, 阿爾巴尼亞, 阿魯巴, 馬來西亞, 馬其頓, 馬拉維, 馬爾代夫, 馬耳他, 馬達加斯加, 馬里, 黑山
排除：
俄羅斯聯邦, 利比亞, 委內瑞拉, 巴貝多, 新喀里多尼亞, 法屬圭亞那, 法屬玻里尼西亞, 烏克蘭, 瓜德羅普島, 留尼汪島, 馬提尼克島
| 運費與處理費 | 每加一件物品 | 運送地點 | 運送方式 | 運送*查看送達備註 |
|---|---|---|---|---|
| 免運費 | 免費 | 美國 | 經濟運送方式 (USPS Media MailTM) | 估計於 6月14日, 五至 6月17日, 一之間送達 運送地點 43230 |
| US $4.99（大約 HK$ 38.99） | 免費 | 美國 | 特快運送方式 (USPS Priority Mail®) | 估計於 6月14日, 五至 6月17日, 一之間送達 運送地點 43230 |
| 處理時間 |
|---|
| 通常會在收到所有款項後的 1 個工作日內發貨。 |
| 稅項 |
|---|
| 結賬時相關稅項可能適用。 進一步了解進一步了解為 eBay 購物繳稅。 |
物品編號 175745813188 的銷售稅
物品編號 175745813188 的銷售稅
賣家會對寄往以下各州的物品收取銷售稅：
| 州／省 | 銷售稅稅率 |
|---|
退貨政策
| 收到物品後聯絡賣家的期限： | 退款方式 |
|---|---|
| 30 日 | 退款 |
賣家負責支付退貨運費。
賣家信用評價 （7,308）
_***o (145)- 買家留下的信用評價。
過去 1 個月
購買已獲認證
This was maybe the best packaged item I've ever received. Great price, very fast shipping - Stellar: 6 stars!
h***o (9199)- 買家留下的信用評價。
過去 1 個月
購買已獲認證
Cool shirt. Thank you!
l***t (1141)- 買家留下的信用評價。
過去 1 個月
購買已獲認證
Thank You