How To Develop Robust Solid Oral Dosage Forms: From Conception To Post-approval

Paperback | October 13, 2016

byBhavishya Mittal

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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 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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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 wor...

Bhavishya Mittal is a Staff Fellow at the Office of Pharmaceutical Quality at the US Food and Drug Administration (FDA) in Silver Spring, MD. Previously, Bhavi was employed as a Senior Scientist in the Formulation Sciences department at Takeda Pharmaceuticals International Company based in Cambridge, MA. Bhavi has a PhD in Materials En...
Format:PaperbackDimensions:190 pages, 8.75 × 6.35 × 0.68 inPublished:October 13, 2016Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0128047313

ISBN - 13:9780128047316

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Table of Contents

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