Commercializing Successful Biomedical Technologies Basic Principles for the Development of Drugs, Diagnostics and Devices
Book contents
- Frontmatter
- Contents
- Foreword by F. L. Douglas
- Preface
- Acknowledgements
- 1 The biomedical drug, diagnostic, and devices industries and their markets
- 2 Markets of interest and market research steps
- 3 Intellectual property, licensing, and business models
- 4 New product development (NPD)
- 5 The regulated market: gateway through the FDA
- 6 Manufacturing
- 7 Reimbursement, marketing, sales, and product liability
- Glossary and acronyms
- Index
- References
6 - Manufacturing
Published online by Cambridge University Press: 05 September 2012
Book contents
- Frontmatter
- Contents
- Foreword by F. L. Douglas
- Preface
- Acknowledgements
- 1 The biomedical drug, diagnostic, and devices industries and their markets
- 2 Markets of interest and market research steps
- 3 Intellectual property, licensing, and business models
- 4 New product development (NPD)
- 5 The regulated market: gateway through the FDA
- 6 Manufacturing
- 7 Reimbursement, marketing, sales, and product liability
- Glossary and acronyms
- Index
- References
Summary
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- Type
- Chapter
- Information
- Commercializing Successful Biomedical TechnologiesBasic Principles for the Development of Drugs, Diagnostics and Devices, pp. 226 - 263Publisher: Cambridge University PressPrint publication year: 2008
References
Douglas McCormick, Small changes, big effects in biological manufacturing, Pharmaceutical Technology, November 2004, (accessed online August 2006).
Guideline of General Principles of Process Validation (May 1987, originally published by CDER, CBER, and CDRH and presently recognized by CDER, CBER, and CVM). www.fda.gov/cder/guidance/pv.htm.
Lefevre, G. Hip replacement patients may face more surgery, CNN, January 17, 2001; accessed at www.cnn.com
Sulzer website: www.sulzer.com
Abboud, L. and Hensley, S. Factory shift: new prescription for drug makers, The Wall Street Journal, (Eastern edn.), September 3, p. A1, 2003.
Microfabrication in Tissue Engineering and Bioartificial Organs (Microsystems), Springer, 1999.CrossRefGoogle Scholar
(ed.). New Drug Approval Process, Accelerating Global Registrations, Informa Healthcare, 4th edn., 2004.Google Scholar
and (ed.). Good Design Practices for GMP Pharmaceutical Facilities, Informa Healthcare, 2005.CrossRefGoogle Scholar
and Fermentation and Biochemical Engineering Handbook: Principles, Process Design, and Equipment, Noyes Publications, 2nd edn., 1996.Google Scholar
(ed.). Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer, Informa Healthcare, 5th edn., 2000.CrossRefGoogle Scholar