BioPharm International, November 2005 - BioPharm International

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BioPharm International, November 2005
Featured Articles, Cover Story
Gas Selection/Management for the Biotech Lab
By Steve Scheuring
Simple practices can increase profit margins and ensure gas supply.
Articles
Form Fluidly Follows Function
By J. Martin Farach , Clarence Lind
In the fast-changing pharmaceutical industry, adaptable planning provides a competitive edge.
From Smart Tags to Brilliant Tags: Advances in Drug Stability Monitoring
By Stephen E. Zweig, Ph.D
"Smart" tags speak only when spoken to. "Brilliant" tags are capable of independent decision-making.
Fermentation & Cell Culture: University Style
By Scott Stevens, Ph.D.
Use of a fermentor for cell culture study advances research in directions previously thought unimaginable.
Risk-Based Cleaning Validation in Biopharmaceutical API Manufacturing
By Edward K. White
Validation of a cleaning process demonstrates that it can reliably and effectively remove residue to an acceptable level.
State Regulation of Clinical Trials
By John C. Serio, Esquire
For those conducting clinical trials, strict adherence to state regulatory requirements makes sound business sense.
Columns and Departments
From the Incoming Editor in Chief: Big Molecules and the Big Picture
By Laura Bush
When devising business strategy or making a career move, one always looks for growth. That's precisely what has brought me to BioPharm International.
Final Word: Clinical Research Organizations Make a Difference
By Bruce Garrett
Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.
Regulatory Beat: Changes and Challenges at FDA
By Jill Wechsler
Facts@FDA...ultimately will contain current product labeling information plus safety data gleaned from adverse event reports.
From the Editor in Chief: New Beginnings
By Carol L. Fisher
BioPharm International is about to embark on another new beginning. You'll remember the magazine (along with the primers, supplements and media kit) had a drastic new beginning in February of 2004 when we launched the major redesign. There were other new beginnings in the past two and one-half years, like five new columns (StreetTalk, Operations Excellence, BioPartnerships, Compliance Briefing and Final Word.) You'll even see a sixth column about legal issues in 2006.
StreetTalk: Memory Drugs: "Viagra for the Brain"
By Brian O'Connell
According to a 2005 study by the American Academy of Neurology, donepezil may improve the memory of Alzheimers patients and those suffering with multiple sclerosis.

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