How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.
By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.
1. Cover image - p. i 2. Title page - p. ii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Author Biography - p. ix 6. Foreword - p. xi 7. Preface - p. xiii 8. Acknowledgments - p. xvii 9. About the Expertise in Pharmaceutical Process Technology Series - p. xix 10. List of Abbreviations and Acronyms - p. xxi 11. Chapter 1. Rules of Drug Product Development - p. 1 12. Chapter 2. Pharmacokinetics and Preformulation - p. 17 13. Chapter 3. Formulation Development - p. 39 14. Chapter 4. Pharmaceutical Unit Operations - p. 69 15. Chapter 5. Process Development - p. 97 16. Chapter 6. Analytical Considerations - p. 125 17. Chapter 7. Process Scale-up, Tech-Transfer, and Optimization - p. 137 18. Chapter 8. Business Acuity - p. 155 19. Index - p. 165
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.
By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.
1. Cover image - p. i 2. Title page - p. ii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Author Biography - p. ix 6. Foreword - p. xi 7. Preface - p. xiii 8. Acknowledgments - p. xvii 9. About the Expertise in Pharmaceutical Process Technology Series - p. xix 10. List of Abbreviations and Acronyms - p. xxi 11. Chapter 1. Rules of Drug Product Development - p. 1 12. Chapter 2. Pharmacokinetics and Preformulation - p. 17 13. Chapter 3. Formulation Development - p. 39 14. Chapter 4. Pharmaceutical Unit Operations - p. 69 15. Chapter 5. Process Development - p. 97 16. Chapter 6. Analytical Considerations - p. 125 17. Chapter 7. Process Scale-up, Tech-Transfer, and Optimization - p. 137 18. Chapter 8. Business Acuity - p. 155 19. Index - p. 165
