Regulatory/GMP Compliance

Feb 01, 2008
BioPharm International
The key to a good graphical presentation is to select the method that best fits the data.
Feb 01, 2008
BioPharm International
By BioPharm International Editors
Best practices from Big Biotech, including how to handle new product introductions.
Feb 01, 2008
BioPharm International
By BioPharm International Editors
Both innovator and generics companies are using analytics to support comparability arguments.
Jan 01, 2008
BioPharm International
By BioPharm International Editors
Design space concepts are key to a successful technology transfer.
Jan 01, 2008
BioPharm International
The new year begins on a note of optimism. A major breakthrough in stem cell research promises to open the door to new biomedical research opportunities. The drawn-out Congressional debate over user-fee reauthorization and drug safety regulation is over, and most parties seem satisfied with resulting compromises. The vaccine industry is experiencing a resurgence after years in the doldrums, with important new vaccines on the market and more under development. And unlike many previous years, the US Food and Drug Administration (FDA) had a confirmed commissioner for all of 2007 and relatively stable leadership.
Dec 01, 2007
BioPharm International
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.
Dec 01, 2007
BioPharm International
Many companies acknowledged that Western regulatory standards are tougher than those in China.
Dec 01, 2007
BioPharm International
By BioPharm International Editors
Developing a process validation strategy early in clinical development is critical for a successful validation program.
Dec 01, 2007
BioPharm International
By BioPharm International Editors
How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
Nov 01, 2007
BioPharm International
The industry needs a clear regulatory pathway for the approval of biosimilars.
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