How to Develop Robust Solid Oral Dosage Forms
From Conception to Post-Approval
Published on 5. October 2016
Book
Paperback/Softback
190 pages
978-0-12-804731-6 (ISBN)
Description
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.
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.
Reviews / Votes
"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 JournalMore details
Series
Language
English
Place of publication
San Diego
United States
Publishing group
Elsevier Science Publishing Co Inc
Target group
Professional and scholarly
Product notice
Paperback (trade)
Dimensions
Height: 229 mm
Width: 152 mm
Thickness: 10 mm
Weight
266 gr
ISBN-13
978-0-12-804731-6 (9780128047316)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
E-Book
10/2016
Academic Press
€50.95
Available for download
Person
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.
Content
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