Computer-Aided Applications in Pharmaceutical Technology

Chapter 1: Quality-by-design in pharmaceutical development

1.1 Introduction

1.2 ICH Q8 guideline

1.3 Regulatory and industry views on QbD

1.4 Scientifically based QbD - examples of application

1.5 Conclusion

Chapter 2: Computer-aided formulation development

2.1 Introduction

2.2 Application of computer-aided techniques in development of pharmaceutical emulsions

2.3 Application of computer-aided techniques in development of microemulsion drug carriers

2.4 Conclusion

Chapter 3: Experimental design application and interpretation in pharmaceutical technology

3.1 Introduction

3.2 Theory

3.3 Examples

Chapter 4: Chemometric methods application in pharmaceutical products and processes analysis and control

4.1 Introduction

4.2 Theory

4.3 Examples

Chapter 5: Neural computing in pharmaceutical products and process development

5.1 Artificial neural networks

5.2 Fuzzy logic

5.3 Decision trees

5.4 Evolutionary computing and genetic algorithms

5.4.1 Theory

5.5 Self-organizing maps

5.6 Conclusion

Chapter 6: Computer-aided biopharmaceutical characterization: gastrointestinal absorption simulation

6.1 Introduction

6.2 Theoretical background

6.3 Model construction

6.4 Parameter sensitivity analysis

6.5 Virtual trial

6.6 Fed vs. fasted state

6.7 In vitro dissolution and in vitro-in vivo correlation

6.8 Biowaiver considerations

6.9 Conclusions

Chapter 7: Computational fluid dynamics: applications in pharmaceutical technology

7.1 Introduction

7.2 Theoretical background

7.3 Application of CFD in pharmaceutical technology

7.4 Conclusion