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Computer-Aided Applications in Pharmaceutical Technology

Book Description

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology.

  • A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology
  • Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Table of Contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. List of figures
  6. List of tables
  7. List of abbreviations
  8. About the editor
  9. About the contributing authors
  10. Introduction
  11. Chapter 1: Quality-by-design in pharmaceutical development
    1. Abstract:
    2. 1.1 Introduction
    3. 1.2 ICH Q8 guideline
    4. 1.3 Regulatory and industry views on QbD
    5. 1.4 Scientifically based QbD - examples of application
    6. 1.5 Conclusion
  12. Chapter 2: Computer-aided formulation development
    1. Abstract:
    2. 2.1 Introduction
    3. 2.2 Application of computer-aided techniques in development of pharmaceutical emulsions
    4. 2.3 Application of computer-aided techniques in development of microemulsion drug carriers
    5. 2.4 Conclusion
  13. Chapter 3: Experimental design application and interpretation in pharmaceutical technology
    1. Abstract:
    2. 3.1 Introduction
    3. 3.2 Theory
    4. 3.3 Examples
  14. Chapter 4: Chemometric methods application in pharmaceutical products and processes analysis and control
    1. Abstract:
    2. 4.1 Introduction
    3. 4.2 Theory
    4. 4.3 Examples
  15. Chapter 5: Neural computing in pharmaceutical products and process development
    1. Abstract:
    2. 5.1 Artificial neural networks
    3. Static neural networks
    4. Construction and testing of the ANN
    5. Unsupervised learning
    6. Limitations of the ANN
    7. 5.2 Fuzzy logic
    8. 5.3 Decision trees
    9. 5.4 Evolutionary computing and genetic algorithms
    10. 5.4.1 Theory
    11. 5.5 Self-organizing maps
    12. 5.6 Conclusion
  16. Chapter 6: Computer-aided biopharmaceutical characterization: gastrointestinal absorption simulation
    1. Abstract:
    2. 6.1 Introduction
    3. 6.2 Theoretical background
    4. 6.3 Model construction
    5. 6.4 Parameter sensitivity analysis
    6. 6.5 Virtual trial
    7. 6.6 Fed vs. fasted state
    8. 6.7 In vitro dissolution and in vitro-in vivo correlation
    9. 6.8 Biowaiver considerations
    10. 6.9 Conclusions
  17. Chapter 7: Computational fluid dynamics: applications in pharmaceutical technology
    1. Abstract:
    2. 7.1 Introduction
    3. 7.2 Theoretical background
    4. 7.3 Application of CFD in pharmaceutical technology
    5. 7.4 Conclusion
  18. Appendix
  19. Index