| 书目名称 | Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development | | 编辑 | Márcia Cristina Breitkreitz,Hector Goicoechea | | 视频video | | | 概述 | Covers the fundamental principles of QbD and AQbD using examples and literature reviews.Provides a detailed theory of different chemometrics methods (DOE; neural networks; multivariate calibration).Di | | 丛书名称 | AAPS Introductions in the Pharmaceutical Sciences | | 图书封面 |  | | 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 | | 出版日期 | Book 2023 | | 关键词 | Quality by Design (QbD); Analytical Quality by Design (AQbD); Design of Experiments (DOE); Pharmaceutic | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-031-31505-3 | | isbn_softcover | 978-3-031-31507-7 | | isbn_ebook | 978-3-031-31505-3Series ISSN 2522-834X Series E-ISSN 2522-8358 | | issn_series | 2522-834X | | copyright | American Association of Pharmaceutical Scientists 2023 |
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发表于 2025-3-21 17:50:23
