Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

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April 2013



This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.


List of Contributors

Chapter 1: Introduction

Christine Seymour and G. V. Reklaitis

Chapter 2: An Overview of Role of Mathematical Models in Implementation of Quality by Design (QbD) Paradigm for Drug Development and Manufacturing

Sharmista Chatterjee, Christine M.V. Moore, Moheb M. Nasr

Chapter 3: The Role of Automatic Process Control in Quality by Design

Mo Jiang, Nicholas C. S. Kee, Xing Yi Woo, Li May Goh, Joshua D. Tice, Lifang Zhou, Reginald B. H. Tan, Charles F. Zukoski, Mitsuko Fujiwara, Zoltan K. Nagy, Paul J. A. Kenis and Richard D. Braatz

Chapter 4: Predictive Distributions for Constructing the ICH Q8 Design Space

John J. Peterson, Mohammad Yahyah, Kevin Lief, and Neil Hodnett

Chapter 5: Design of novel integrated pharmaceutical processes: A model-based approach

Alicia Román-Martínez, John M. Woodley and Rafiqul Gani

Chapter 6: Methods and tools for Design Space identification in pharmaceutical development

Boukouvala, F., Muzzio, F.J, M. G. Ierapetritou

Chapter 7: Using Quality by Design Principles as a Guide for Designing a Process Control Strategy

Christopher L. Burcham, Mark LaPack, Joseph R. Martinelli, Neil McCracken

Chapter 8: A Strategy for Tablet Active Film Coating Formulation Development Using a Content Uniformity Model and Quality-by-Design Principles

Wei Chen, Jennifer Wang, Divyakant Desai, Shih-Ying Chang, San Kiang and Olav Lyngberg

Chapter 9: Quality-by-Design (QbD): Process Trajectory Development for a Dynamic Pharmaceutical Co-precipitation Process Based on an Integrated Real-Time Process Monitoring Strategy

Huiquan Wu and Mansoor A. Khan

Chapter 10: Application of Advanced Simulation Tools for Establishing Process Design Spaces within the Quality-by-Design Framework

Siegfried Adam, Daniele Suzzi, Gregor Toschkoff and Johannes G. Khinast

Chapter 11: Design Space Definition: A Case Study - Small Molecule Lyophilized Parenteral

Linas Mockus, David LeBlond, Gintaras V. Reklaitis, Prabir K. Basu, Tim Paul, Nathan Pease, Steven L. Nail and Mansoor A. Khan

Chapter 12: Enhanced Process Design and Control of a Multiple-Input Multiple-Output Granulation Process

Rohit Ramachandran

Chapter 13: A perspective on the implementation of QbD on manufacturing through control system: The Fluidized Bed Dryer control with MPC and NIR spectroscopy case

Ariel Vargas, Leonel Quiñones, Luis Obregón, and Carlos Velázquez

Chapter 14: Knowledge Management in Support of QbD

G. Joglekar, G. V. Reklaitis, A. Giridhar, L. Mockus

EAN: 9780470942376
ISBN: 0470942371
Untertitel: Sprache: Englisch.
Verlag: John Wiley and Sons Ltd
Erscheinungsdatum: April 2013
Seitenanzahl: 416 Seiten
Format: gebunden
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