"Readers will get a good overview of each topic, alongside practical advice and illustrative case studies. Decision trees and reference tables are particularly useful. ... This excellent book provides a great introduction for anyone starting a career in formulation science, and is a perfect starting point for trouble shooting issues throughout the formulation development process." --Emma McConnell, The Pharmaceutical Journal

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.
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1. Rules of Drug Product Development2. Pharmacokinetics and Preformulation3. Formulation Development4. Pharmaceutical Unit Operations5. Process Development6. Analytical Considerations7. Process Scale-up, Tech-Transfer, and Optimization8. Business Acuity
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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
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
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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Produktdetaljer

ISBN
9780128047316
Publisert
2016-10-05
Utgiver
Elsevier Science Publishing Co Inc
Vekt
320 gr
Høyde
229 mm
Bredde
152 mm
Aldersnivå
P, 06
Språk
Product language
Engelsk
Format
Product format
Heftet
Antall sider
190

Forfatter

Biografisk notat

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.