Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development
暫譯: 製藥產業中的多型性：固體形態與藥物開發
Hilfiker, Rolf, Von Raumer, Markus
- 出版商: Wiley-Vch
- 出版日期: 2019-04-29
- 售價: $6,560
- 貴賓價: 9.5 折 $6,232
- 語言: 英文
- 頁數: 512
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 3527340408
- ISBN-13: 9783527340408
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商品描述
As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided.
Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.
商品描述(中文翻譯)
《製藥產業中的多型性 - 固體形態與藥物開發》強調了多型性在現代製藥化學中的重要性，並專注於設計品質（Quality by Design, QbD）概念。該書通過案例研究涵蓋了所有重要議題，從性質和結晶、熱力學、分析學和理論建模，一直到專利問題。
因此，本書強調了固態化學在化學和製藥開發中的重要性。它強調了固態問題的重要性、避免問題所需的方法以及固態性質所提供的機會。作者涵蓋了真正的多型體以及溶劑合物和水合物，同時提供了物理化學性質、結晶熱力學、量子力學建模和放大生產的資訊。重要的分析工具用於表徵固態形態和定量混合物的總結，並提供了有關產業中固態開發過程的案例研究。
本書由該領域的公認專家撰寫，是製藥、農藥和精細化學品公司中的研究人員、專案經理和品質保證經理，以及有機固態化學的學術界和新手的高品質參考資料。
作者簡介
Rolf Hilfiker is vice president and head of the department Solid-State Development at Solvias AG in Kaiseraugst, Switzerland. He obtained his PhD in physical chemistry from Basel University (Switzerland) and then did postdoctoral work at Stony Brook University (New York). He returned to Basel University as a research fellow and then moved to Ciba-Geigy (now Novartis) in Basel. In 1997 he became head of the Stability & Kinetics group at Novartis. In 1999 he participated in a management buyout to form Solvias AG. He has taught physical chemistry in New York and Basel, as well as numerous courses in solid-state development in Europe, Asia, and the US.
Markus von Raumer is director and group leader of Preformulation and Preclinical Galenics at Idorsia Pharmaceuticals Ltd. in Allschwil, Switzerland. He obtained his PhD in physical chemistry from the University of Fribourg (Switzerland) and then did postdoctoral work in the field of mass spectrometry at the University of Warwick (UK). In 1997 he became head of laboratory of Physical Chemistry at Novartis in Basel, Switzerland. Two years later he moved to Solvias AG in Basel where he was project manager for Solid-State Development until 2008. He then joined Actelion Pharmaceuticals Ltd. in Allschwil where he built up and led the Material Science lab until 2017.
作者簡介(中文翻譯)
羅夫·希爾菲克（Rolf Hilfiker）是瑞士凱瑟勞斯特的Solvias AG固態開發部門的副總裁和負責人。他在巴塞爾大學（瑞士）獲得物理化學博士學位，隨後在紐約的石溪大學進行博士後研究。他回到巴塞爾大學擔任研究員，然後轉到巴塞爾的Ciba-Geigy（現為諾華公司）。1997年，他成為諾華公司的穩定性與動力學小組負責人。1999年，他參與管理層收購，成立了Solvias AG。他曾在紐約和巴塞爾教授物理化學，並在歐洲、亞洲和美國教授多門固態開發課程。
馬庫斯·馮·勞默（Markus von Raumer） 是瑞士阿爾斯基維爾的Idorsia Pharmaceuticals Ltd.的預配方和臨床前藥學部門的主任和小組負責人。他在弗里堡大學（瑞士）獲得物理化學博士學位，隨後在英國華威大學的質譜領域進行博士後研究。1997年，他成為瑞士巴塞爾諾華公司的物理化學實驗室負責人。兩年後，他轉到巴塞爾的Solvias AG，擔任固態開發的項目經理，直到2008年。之後，他加入了位於阿爾斯基維爾的Actelion Pharmaceuticals Ltd.，在那裡建立並領導材料科學實驗室，直到2017年。
