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
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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
Bhavishya Mittal is an Associate Director in the Oral and Implants Product Development Department at Allergan Pharmaceuticals in Irvine, CA. Prior to Allergan, Bhavi worked at the US Food and Drug Administration (FDA), Takeda Pharmaceuticals and Astellas Pharmaceuticals. Bhavi has a PhD in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India). Bhavi has 16 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings. He is the past Vice Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS. His research interests include formulation design, process engineering, scale-up/tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing. In addition to technical topics, Bhavi maintains an active interest in general risk mitigation strategies, efficient outsourcing management, business analytics, strategic decision-making sciences, and financial engineering.