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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 fo… Read more
LIMITED OFFER
Immediately download your ebook while waiting for your print delivery. No promo code needed.
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.
Pharmaceutical scientists in formulation and research and development, academic professors and graduate students in pharmaceutical sciences and pharmacology
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
BM
Bhavishya Mittal is the Vice-President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro, Bhavi worked at Kronos Bio, AbbVie, US FDA, Takeda, and Astellas Pharmaceuticals. Bhavi is also an adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA). He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India). Bhavi has 21+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings. He is the Chair for the Manufacturing Sciences and Engineering (MSE) community of AAPS. He is the author of 3 published books (with 25 combined chapters), 4 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to pharmaceutical manufacturing sciences.