Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture.

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Bibliographic Details
Main Author: Reklaitis, Gintaras
Other Authors: Seymour, Christine, Garc?a-Munoz, Salvador
Format: eBook
Language:English
Published: New York : American Institute of Chemical Engineers, 2017.
Subjects:
Pharmaceutical industry > Quality control.
Pharmaceutical industry > Quality control
Online Access:Click for online access
Table of Contents:
  • Title Page; Copyright Page; Contents; List of Contributors; Preface; Chapter 1 Introduction; 1.1 Quality by Design Overview; 1.2 Pharmaceutical Industry; 1.3 Quality by Design Details; 1.4 Chapter Summaries; References; Chapter 2 An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture ; 2.1 Introduction; 2.2 Overview of Models; 2.3 Role of Models in QbD; 2.3.1 CQA; 2.3.2 Risk Assessment; 2.3.3 Design Space; 2.3.4 Control Strategy; 2.4 General Scientific Considerations for Model Development.
  • 2.4.1 Models for Process Characterization2.4.2 Models for Supporting Analytical Procedures; 2.4.3 Models for Process Monitoring and Control; 2.5 Scientific Considerations for Maintenance of Models; 2.6 Conclusion; References; Chapter 3 Role of Automatic Process Control in Quality by Design ; 3.1 Introduction; 3.2 Design of Robust Control Strategies; 3.3 Some Example Applications of Automatic Feedback Control; 3.4 The Role of Kinetics Modeling; 3.5 Ideas for a Deeper QbD Approach; 3.6 Summary; Acknowledgments; References.
  • Chapter 4 Predictive Distributions for Constructing the ICH Q8 Design Space 4.1 Introduction; 4.2 Overlapping Means Approach; 4.3 Predictive Distribution Approach; 4.4 Examples; 4.4.1 A Mechanistic Model Example; 4.4.2 An Empirical Model Example; 4.5 Summary and Discussion; Acknowledgment; References; Chapter 5 Design of Novel Integrated Pharmaceutical Processes: A Model-Based Approach ; 5.1 Introduction; 5.2 Problem Description; 5.2.1 Mathematical Formulation; 5.2.2 Solution Approach; 5.3 Methodology; 5.3.1 Superstructure; 5.3.2 Model Development; 5.3.3 Decomposition Strategy.
  • 5.4 Application: Case Study5.4.1 Stage 1: Problem Definition; 5.4.2 Stage 2: Data/Information Collection/Analysis; 5.4.3 Stage 3: Superstructure, Model Development, and Decomposition Strategy; 5.4.4 Stage 4: Generation of Feasible Candidates and Screening; 5.4.5 Stage 5: Screening by Process Model; 5.4.6 Stage 6: Evaluation of the Feasible Options: Calculation of the Objective Function; 5.5 Conclusions; References; Chapter 6 Methods and Tools for Design Space Identification in Pharmaceutical Development ; 6.1 Introduction; 6.2 Design Space: A Multidisciplinary Concept.
  • 6.3 Integration of Design Space and Control Strategy6.4 Case Studies; 6.4.1 Design Space of a Continuous Mixer: Use of Data-Driven-Based Approaches; 6.4.2 Roller Compaction Case Study: Integration of Control Strategy and Its Effects on the Design Space; 6.4.2.1 Deterministic Design Space; 6.4.2.2 Stochastic Design Space; 6.4.2.3 Effect of Control Strategies on the Design Space; 6.5 Conclusions; Acknowledgment; References; Chapter 7 Using Quality by Design Principles as a Guide for Designing a Process Control Strategy ; 7.1 Introduction.

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