Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients
暫譯: 製藥產業中的化學工程:活性藥物成分

Am Ende, David J., Am Ende, Mary T.

  • 出版商: Wiley
  • 出版日期: 2019-04-23
  • 售價: $12,530
  • 貴賓價: 9.5$11,904
  • 語言: 英文
  • 頁數: 1168
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1119285860
  • ISBN-13: 9781119285861
  • 海外代購書籍(需單獨結帳)

商品描述

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition

The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book's regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API's) and 2) Drug Product Design, Development and Modeling.

The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition:

- Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety

- Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying

- Presents updated and expanded example calculations

- Includes contributions from noted experts in the field

Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

商品描述(中文翻譯)

《製藥產品的開發與製造指南,專為業界專業人士撰寫,修訂第二版》

修訂更新的《製藥產業中的化學工程》第二版是一本實用的書籍,強調化學和化學工程。該書的法規品質策略針對製藥產品的藥用活性成分的開發與製造。擴充的第二版包含修訂內容,並有許多新的案例研究和額外的範例計算,對化學工程師具有吸引力。第二版分為兩本獨立的書籍:1) 藥用活性成分 (API) 和 2) 藥品設計、開發與建模。

藥用活性成分的書籍專注於與製藥產品的活性成分的開發與製造相關的化學、化學工程和單元操作。藥物物質操作部分包括化學反應、混合、蒸餾、萃取、結晶、過濾、乾燥以及濕磨和乾磨的資訊。此外,該書還包括許多針對批量和連續藥物物質製藥操作的過程建模和現代軟體工具的應用。這本更新的第二版:

- 包含30個新的章節或針對API的修訂章節,涵蓋主題包括:設計製造品質、計算方法、連續製造、結晶和最終形式、過程安全
- 擴展了放大、連續處理、熱力學及熱力學建模的應用、過濾和乾燥的主題
- 提供更新和擴展的範例計算
- 包含來自該領域知名專家的貢獻

本書專為製藥工程師、化學工程師、本科生和研究生以及製藥科學和製造領域的專業人士撰寫,《製藥產業中的化學工程》第二版專注於開發和化學工程,以及與藥物物質和產品的設計、配方和製造相關的操作。

作者簡介

David J. am Ende, PhD, is President of Nalas Engineering Services, Inc. Previously, he was a Research Fellow at Pfizer Inc. in Chemical Research & Development. He has over 25 years's experience in chemical and pharmaceutical process development.

Mary T. am Ende, PhD, is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling.

作者簡介(中文翻譯)

David J. am Ende, PhD, 是 Nalas Engineering Services, Inc. 的總裁。之前,他曾在 Pfizer Inc. 的化學研究與開發部門擔任研究員。他在化學和製藥過程開發方面擁有超過 25 年的經驗。

Mary T. am Ende, PhD, 是 Lyndra Therapeutics, Inc. 的過程開發副總裁。之前,她曾在 Pfizer, Inc. 的藥品設計部門擔任研究員。她在藥品配方、過程開發和計算建模方面擁有超過 25 年的經驗。

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