Narrow your search

Library

AP (1)

KDG (1)

KU Leuven (1)

Odisee (1)

Thomas More Kempen (1)

Thomas More Mechelen (1)

UCLL (1)

ULB (1)

ULiège (1)

VIVES (1)

More...

Resource type

book (2)

digital (1)


Language

English (2)


Year
From To Submit

2023 (2)

Listing 1 - 2 of 2
Sort by

Book
Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Authors: ---
ISBN: 3031315057 3031315049 Year: 2023 Publisher: Cham : Springer International Publishing : Imprint: Springer,

Loading...
Export citation

Choose an application

Bookmark

Abstract

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.

Keywords

Drug Development. --- Drug Design. --- Nanoparticle Drug Delivery System. --- Risk Evaluation and Mitigation --- ETASU --- Elements to Assure Safe Use --- Computer-Aided Drug Design --- Computerized Drug Design --- Drug Modeling --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs --- Drug Modelings --- Pharmaceutical Designs --- NDDSs --- Nano Delivery System --- Nano Drug Delivery Systems --- Nano-Drug Delivery System --- Nanoparticle Based Drug Delivery System --- Delivery System, Nano --- Delivery System, Nano-Drug --- Delivery Systems, Nano --- Delivery Systems, Nano-Drug --- Nano Delivery Systems --- Nano Drug Delivery System --- System, Nano Delivery --- System, Nano-Drug Delivery --- Systems, Nano Delivery --- Systems, Nano-Drug Delivery --- Medication Development --- Pharmaceutical Development --- Computational Prediction of Drug-Target Interactions --- Drug Target Prediction --- Development, Drug --- Development, Medication --- Development, Pharmaceutical --- Drug Target Predictions --- Prediction, Drug Target --- Target Prediction, Drug --- Drug development. --- Drugs --- Pharmaceutical industry --- Design. --- Quality control. --- Drug design --- Pharmaceutical design --- Drug development --- Development of drugs --- New drug development --- Pharmacology --- Pharmacy --- Development --- Pharmacology. --- Pharmaceutical chemistry. --- Pharmaceutics. --- Chemistry, Medical and pharmaceutical --- Chemistry, Pharmaceutical --- Drug chemistry --- Medical chemistry --- Medicinal chemistry --- Pharmacochemistry --- Chemistry --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Physiological effect


Multi
Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Authors: ---
ISBN: 9783031315053 9783031315046 9783031315060 9783031315077 Year: 2023 Publisher: Cham Springer International Publishing

Loading...
Export citation

Choose an application

Bookmark

Abstract

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.

Listing 1 - 2 of 2
Sort by