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 Levin
- Discusses 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
As part of the Expertise in Pharmaceutical Process Technology Series, this book uses a hands-on approach to cover the development process of solid oral dosage forms
Bhavishya Mittal is an Associate Director in the Oral and Implants Product Development DeplÛ
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