Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach
暫譯: 生物製藥產業中的數學與統計技能：實用方法
Pitman, Arkadiy, Sverdlov, Oleksandr, Pearce, L. Bruce
- 出版商: CRC
- 出版日期: 2019-07-16
- 售價: $5,230
- 貴賓價: 9.5 折 $4,969
- 語言: 英文
- 頁數: 227
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 1498769799
- ISBN-13: 9781498769792
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商品描述
Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry.
Features:
- Describes a system of principles for pragmatic problem solving in clinical drug development.
- Discusses differences in the work of a biostatistician in small pharma and big pharma.
- Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels.
- Describes some useful statistical background that can be capitalized upon in the drug development enterprise.
- Explains some hot topics and current trends in biostatistics in simple, non-technical terms.
- Discusses incompleteness of any system of standard operating procedures, rules and regulations.
- Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial.
- Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed.
- Discusses realistic planning of open-ended projects.
商品描述(中文翻譯)
《生物製藥產業中的數學與統計技能：務實的方法》描述了一種高效解決問題的哲學，並以與臨床藥物開發中的生物統計功能相關的範例進行展示。這本書旨在分享作者在生物製藥產業多年相關工作中獲得的精華。該書對於不同資歷層級的生物製藥產業統計學家以及考慮在此產業從事生物統計相關職業的研究生將會非常有用。
特點：
- 描述了一套在臨床藥物開發中務實解決問題的原則系統。
- 討論了小型製藥公司與大型製藥公司中生物統計學家的工作差異。
- 解釋了統計程式設計和數據管理對生物統計的重要性/相關性，以及在各個層級整合的必要性。
- 描述了一些在藥物開發企業中可以利用的有用統計背景。
- 以簡單、非技術性的術語解釋生物統計中的一些熱門話題和當前趨勢。
- 討論了任何標準作業程序、規則和法規系統的不完整性。
- 提供了評分系統的分類，並提出了一種新穎的方法來評估已完成隨機臨床試驗的安全結果。
- 在一個問題重重的輸血領域中展示了問題解決哲學的應用，該領域中許多研究性化合物已經失敗。
- 討論了開放式項目的現實規劃。
作者簡介
Arkadiy Pitman, MSc is senior director of biostatistics and data management at HBO2 Therapeutics. His experience includes over 20 years of teaching mathematics, logic, statistics, and computer science, as well as over 20 years of work in US small pharma environment, covering data management, statistical programming, biostatistics, regulatory, and medical writing.
Oleksandr Sverdlov, PhD is neuroscience disease area lead statistician in early clinical development at Novartis Pharmaceuticals. He has been actively involved in research on adaptive designs for clinical trials and edited a monograph Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects (CRC Press).
L. Bruce Pearce, PhD has background in pharmacology and toxicology. Since 2009 he has served as a consultant to very early and late stage biotechnology and pharmaceutical companies for the development of small molecule-based drugs, biotechnology-derived natural and recombinant biotherapeutics, and medical devices.
作者簡介(中文翻譯)
阿卡迪·皮特曼（Arkadiy Pitman），碩士，現任 HBO2 Therapeutics 的生物統計與數據管理高級總監。他擁有超過 20 年的數學、邏輯、統計學和計算機科學教學經驗，以及超過 20 年在美國小型製藥環境中的工作經歷，涵蓋數據管理、統計編程、生物統計、法規及醫學寫作等領域。
奧列克桑德·斯維爾德洛夫（Oleksandr Sverdlov），博士，現任諾華製藥（Novartis Pharmaceuticals）早期臨床開發的神經科學疾病領域首席統計師。他積極參與臨床試驗的自適應設計研究，並編輯了專著《現代自適應隨機臨床試驗：統計與實踐方面》（Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects，CRC Press）。
L. 布魯斯·皮爾斯（L. Bruce Pearce），博士，擁有藥理學和毒理學背景。自 2009 年以來，他一直擔任早期和晚期生物技術及製藥公司的顧問，專注於小分子藥物、生物技術衍生的天然和重組生物治療劑以及醫療設備的開發。
