Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Breitkreitz, Márcia Cristina, Goicoechea, Hector
- 出版商: Springer
- 出版日期: 2024-07-15
- 售價: $5,710
- 貴賓價: 9.5 折 $5,425
- 語言: 英文
- 頁數: 266
- 裝訂: Quality Paper - also called trade paper
- ISBN: 3031315073
- ISBN-13: 9783031315077
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商品描述
Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed.
Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown.
Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.
商品描述(中文翻譯)
本專著由來自學術界、製藥業及全球藥典的二十五位作者撰寫，涵蓋了設計品質（Quality by Design, QbD）和分析品質設計（Analytical Quality by Design, AQbD）的基本原則及應用，以實用且具教學性的方式呈現。書中首先描述了在製藥開發中實施QbD框架的動機及迫切需求，並定義了其主要元素：品質目標產品特徵（Quality Target Product Profile, QTTP）、關鍵品質屬性（Critical Quality Attributes, CQAs）、關鍵過程參數（Critical Process Parameters, CPPs）、關鍵材料屬性（Critical Material Attributes, CMAs），以及使用多變量實驗設計（Design of Experiments, DOE）方法的重要性。書中還討論了生命週期及監管視角。
三個章節專門探討從篩選到優化設計的DOE理論。此外，還提供了關於建模和數據處理的全面討論。書中包含了QbD和DOE在不同劑型的製藥產品及過程中的實際應用，並提供了最具代表性的製藥過程的輸入過程變數、材料屬性、中間及最終品質屬性的實用指南。分析品質設計（AQbD）也被深入探討，包括風險分析、分析目標特徵（Analytical Target Profile, ATP）、可操作方法設計區域（Method Operable Design Region, MODR）及生命週期方法，並考慮到藥典及監管的視角。書中展示了一個基於AQbD程序的新型色譜法的詳細範例，用於製藥外用產品的品質控制。
最後，書中還介紹了針對生物活性化合物提取研究的先進統計方法和DOE技術。本書提供的大量資訊，為QbD、AQbD及DOE原則提供了全面的視角，這些都是現代製藥及分析開發的基本工具。
作者簡介
Márcia Cristina Breitkreitz has worked since 2014 as Professor in the Chemistry Institute of the University of Campinas (UNICAMP), coordinating the Laboratory of Pharmaceutical Research and Chemometrics (LabFarQui). She was a researcher in Chemometrics from 2006-2007 at the International Institute of Pharmaceutical Research (IIPF, Brazil) and coordinator of Research and Development (R&D) from 2007 to 2009, where she started the implementation of chemometrics methods for pharmaceutical development. She received her PhD (2013) degree from UNICAMP, with a project aimed at using hyperspectral imaging (NIR/Raman) and multivariate analysis to develop stable pharmaceutical formulations. Her major research interests are related to Chemometrics applied to the development of pharmaceutical products and processes according to the strategy of Quality by Design (QbD); development of analytical methods based Analytical Quality by Design (AQbD) and the use of vibrational spectroscopy (IR, NIR and Raman, point and imaging) for pharmaceutical development and troubleshooting. In addition to her research work and teaching (graduate and undergraduate levels), Prof. Marcia is dedicated to courses and consultancy on relevant topics to the pharmaceutical industry, especially related to Chemometrics within the context of Quality by Design.
Héctor C. Goicoechea was born in Santa Fe, Argentina, on May 15, 1961. He received his Ph.D. (2000) from the National University of Rosario. After a postdoctoral research at North Dakota State University, USA, he joined the University of Litoral, Santa Fe (2004), where he is Full Professor of Analytical Chemistry/Chemometrics. He is fellow (Senior Researcher) of the National Research Council of Argentina (CONICET), and has founded a research group (LADAQ). His works in the development of analytical methods based on spectroscopy, separations and electrochemistry coupled to chemometrics. He published more than 220 papers in well-known international journals, two books, 8 book chapters and has supervised thirteen Ph.D. Theses.
作者簡介(中文翻譯)
Márcia Cristina Breitkreitz 自2014年以來在坎皮納斯大學（UNICAMP）化學研究所擔任教授，負責藥物研究與化學計量學實驗室（LabFarQui）的協調工作。她於2006年至2007年在巴西國際藥物研究所（IIPF）擔任化學計量學研究員，並於2007年至2009年擔任研究與開發（R&D）協調員，開始實施化學計量學方法以促進藥物開發。她於2013年獲得UNICAMP的博士學位，研究專案旨在利用高光譜成像（NIR/Raman）和多變量分析來開發穩定的藥物配方。她的主要研究興趣與應用於藥物產品和過程開發的化學計量學有關，特別是根據設計品質（Quality by Design, QbD）策略進行的研究；基於分析品質設計（Analytical Quality by Design, AQbD）開發分析方法，以及利用振動光譜（IR、NIR和Raman，點測和成像）進行藥物開發和故障排除。除了研究工作和教學（研究生和本科生層級）外，Marcia教授還致力於針對藥物產業相關主題的課程和諮詢，特別是與設計品質背景下的化學計量學有關的內容。
Héctor C. Goicoechea 於1961年5月15日出生於阿根廷聖菲。他於2000年獲得羅薩里奧國立大學的博士學位。完成在美國北達科他州立大學的博士後研究後，他於2004年加入聖菲的利托拉大學，擔任分析化學/化學計量學的全職教授。他是阿根廷國家研究委員會（CONICET）的研究員（高級研究員），並創立了一個研究小組（LADAQ）。他的研究工作集中於基於光譜學、分離技術和電化學結合化學計量學的分析方法開發。他在知名國際期刊上發表了超過220篇論文，出版了兩本書和8個書章，並指導了十三篇博士論文。
