BioPharm International, December 2007 - BioPharm International

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BioPharm International, December 2007
Features
Developing a Sound Process Validation Strategy
By David M. Fetterolf
Developing a process validation strategy early in clinical development is critical for a successful validation program.
Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 2
By Balazs Hunek , Alan Cheng, PhD , John Capettini
The second of a two part article.
Quality by Design in the CMO Environment
By Susan Cook , Katherine A. Patton , L. Rochelle Bazemore, PhD
How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
Columns and Departments
China as a Biopharmaceutical Powerhouse: Just a Matter of Time
By Eric S. Langer
China's pharma industry represents 5% of the world total. By 2010, China is expected to become the world's fifth largest pharmaceutical market.
Taking a Closer Look
By Laura Bush
Many companies acknowledged that Western regulatory standards are tougher than those in China.
Life Sciences and Socially Responsible Investing
By Brian O'Connell
More than $1 out of every $9 under professional management in the United States is involved in socially responsible investing.
Has the Era of Blockbuster Drugs Come to an End?
By Nafees Malik
Eighty drugs will lose patent protection between 2007 and 2011.
Personalized Medicine May Rationalize the Coverage of Specialty Therapies
By Jill Wechsler
The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.

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