How to Develop Robust Solid Oral Dosage Forms

From Conception to Post-Approval

AvBhavishya Mittal

Häftad, Engelska, 2016

Del i serien Expertise in Pharmaceutical Process Technology

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Beskrivning

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

Produktinformation

Utgivningsdatum:2016-10-05
Mått:152 x 229 x 14 mm
Vikt:320 g
Format:Häftad
Språk:Engelska
Serie:Expertise in Pharmaceutical Process Technology
Antal sidor:190
Förlag:Elsevier Science
ISBN:9780128047316

Utforska kategorier

Farmakologi inom Medicin

Mer om författaren

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.

Recensioner i media

"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

Innehållsförteckning

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