The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines.
Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries.
1. 20.1 Introduction to sterilization - p. 695 2. 20.2 Sterilization versus disinfection - p. 697 3. 20.3 Process of microbial destruction - p. 699 4. 20.4 Sterility assurance level - p. 702 5. 20.5 Steam sterilization - p. 712 6. 20.6 Dry-heat sterilization and depyrogenation - p. 726 7. 20.7 Radiation sterilization - p. 738 8. 20.8 Ethylene oxide (EO) sterilization - p. 738 9. 20.9 Sterilization by filtration - p. 742 10. 20.10 Liquid chemical sterilization - p. 746 11. 20.11 Newer perspectives and technological advancements in sterilization - p. 760 12. 20.12 Terminal sterilization - p. 769 13. 20.13 Aseptic processing - p. 772 14. 20.14 Sterilization-in-place technology and validation - p. 774 15. 20.15 Sterilization of dry powders - p. 776 16. 20.16 Sterilization of excipients and active pharmaceutical ingredients - p. 777 17. 20.17 Sterilization of biotechnology products - p. 777 18. 20.18 Sterilization of nanoformulations - p. 779 19. 20.19 Summary and conclusions - p. 780 20. References - p. 781 21. Further reading - p. 781 22. Chapter 21. Achieving sterility in biomedical and pharmaceutical products (part-II): radiation sterilization - p. 789 23. Chapter 22. Summary of Current Regulatory Perspective of Medical Devices - p. 849 24. Chapter 23. Clinical trial design for medical devices “emerging pharmaceuticals” - p. 881 25. Chapter 24. Recent Updates on Medical Device Safety and Risk Management - p. 901 26. Index - p. 921
The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines.
Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries.
1. 20.1 Introduction to sterilization - p. 695 2. 20.2 Sterilization versus disinfection - p. 697 3. 20.3 Process of microbial destruction - p. 699 4. 20.4 Sterility assurance level - p. 702 5. 20.5 Steam sterilization - p. 712 6. 20.6 Dry-heat sterilization and depyrogenation - p. 726 7. 20.7 Radiation sterilization - p. 738 8. 20.8 Ethylene oxide (EO) sterilization - p. 738 9. 20.9 Sterilization by filtration - p. 742 10. 20.10 Liquid chemical sterilization - p. 746 11. 20.11 Newer perspectives and technological advancements in sterilization - p. 760 12. 20.12 Terminal sterilization - p. 769 13. 20.13 Aseptic processing - p. 772 14. 20.14 Sterilization-in-place technology and validation - p. 774 15. 20.15 Sterilization of dry powders - p. 776 16. 20.16 Sterilization of excipients and active pharmaceutical ingredients - p. 777 17. 20.17 Sterilization of biotechnology products - p. 777 18. 20.18 Sterilization of nanoformulations - p. 779 19. 20.19 Summary and conclusions - p. 780 20. References - p. 781 21. Further reading - p. 781 22. Chapter 21. Achieving sterility in biomedical and pharmaceutical products (part-II): radiation sterilization - p. 789 23. Chapter 22. Summary of Current Regulatory Perspective of Medical Devices - p. 849 24. Chapter 23. Clinical trial design for medical devices “emerging pharmaceuticals” - p. 881 25. Chapter 24. Recent Updates on Medical Device Safety and Risk Management - p. 901 26. Index - p. 921
