How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval

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.

Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael LevinDiscusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Chapter 1. Rules of Drug Product Development

Chapter 2. Pharmacokinetics and Preformulation

Chapter 3. Formulation Development

Chapter 4. Pharmaceutical Unit Operations

Chapter 5. Process Development

Chapter 6. Analytical Considerations

Chapter 7. Process Scale-up, Tech-Transfer, and Optimization

Chapter 8. Business Acuity