BioPharm International, March 2006 - BioPharm International

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BioPharm International, March 2006
Special Section
A Signal-to-Noise Ratio is No Subsitute for a Brain
By Terry Orchard
Signal-to-noise ratios are useful in robust engineering to design products and processes that consistently deliver on target.
Articles
Automated Process Control for the Development Laboratory
By Meg Kay
Minimum disruption and maximum gain result when adopting a distributed process control and data management system for a cell culture and fermentation lab.
Biopartnering Down Under
By Helen Hill
Australia's pharmaceutical industry as a whole turns over approximately US$10.7 billion a year and spends some US$384 million annually on research and development.
Using Volumetric Flow to Scaleup Chromatographic Processes
By Steffen Kidal , Ole Elvang Jensen
Extra column effects must be accounted for to make a valid comparison
Columns and Departments
Regulatory Beat: Biotech Innovation Benefits From Streamlined Manufacturing Policy
By Jill Wechsler
As part of its campaign to facilitate research on drugs and medical products, the Food and Drug Administration (FDA) recently issued new policies to encourage sponsors to conduct more informative and less costly early clinical trials. A new guidance on exploratory investigational drug applications (INDs) explains how scientists in industry and academia may test very small doses of a candidate compound to detect any pharmacologic effect before investing in more extensive in vitro and animal studies required for conventional phase 1 trials. The goal is to quickly identify products that show some promise of efficacy, and to halt research on those that fail to hit preliminary targets.
From the Editor in Chief: We Need to Talk
By Laura Bush
In recent days, several different colleagues, in separate conversations about the industry, made remarkably similar comments.
StreetTalk: States' Battle Over Biotech Business Begets Brainstorming
By Brian O'Connell
The above statement reflects the opinion of a growing number of US governors and key state lawmakers.
Operations Excellence: BioPharmaceutical Operations Excellence -- 2006 and Beyond
By Marc Puich
. . . Popular consortium meetings have focused on successful use of tools to drive improvement in cycle time reduction, deviation reduction, and improved production efficiency.
Final Word: The Constant Gardner Meets the China Syndrome
By K. John Morrow, Jr., PhD
A powerful film will have a hundred times the impact of a touchy-feely commercial.

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