Title Page
Contents
초록 9
Abstract 11
Chapter I. Development control strategy for MCC variability 13
I.1. Introduction 13
I.2. Materials and method 16
I.2.1. Materials 16
I.2.2. QbD approach for formulation development 16
I.2.3. Investigation of the effect of MCC variability on the design space 21
I.3. Results and Discussion 24
I.3.1. QbD approach for optimizing the formulation 24
I.3.2. Effect of MCC variability on drug product quality and the design space 40
I.3.3. Establishment of a dissolution prediction model based on PCA-ANNs 66
I.4. Conclusion 77
Chapter II. Development control strategy for PVP variability 79
II.1. Introduction 79
II.2. Materials and Methods 82
II.2.1. Materials 82
II.2.2. QbD approach for optimizing the formulation 82
II.2.3. Effect of PVP variability on the design space 87
II.3. Results and Discussion 90
II.3.1. QbD approach for formulation development 90
II.3.2. Effect of PVP variability on drug product quality and design space 103
II.4. Conclusion 133
Reference 134