BioPharm International
October 01, 2004
Columns and Departments
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Let's be frank. Love doesn't make the world go round —money does, especially if you're developing a promising technology but you're facing ten or fifteen more years of bench time and clinical trials before you can unveil a marketable product.
October 01, 2004
Columns and Departments
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10
We've gone beyond the days when corporate America's idea of a healthy outing was a company softball game complete with beer and hot dogs.
October 01, 2004
Bioequivalence
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Establishing bioequivalence is difficult for drugs with high inter-subject variability or strong dependence on the physiological state of the gut.
October 01, 2004
Columns and Departments
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10
Even if FDA does not require pharma companies to co-market a diagnostic test, insurers and health plans may pressure industry to do so, according to Robert Temple of CDER.
October 01, 2004
International BioMarket
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Though still relatively modest by international standards, the Netherlands' biotechnology industry has made impressive gains in recent years and now provides investors with a compelling alternative to more established European "heavyweights" such as Scandinavia, Switzerland, and the United Kingdom.
October 01, 2004
Validation
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The relationship between "valid" or "suitable and validated" is often overlooked, but there is a high price when "validated" test systems are simply inappropriate.
October 01, 2004
Quality
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Wyeth BioPharma has identified cycle-time reduction as critical to customer responsiveness and the success of commercial and pipeline products. In formulating a plan of attack, the company focused on two aspects of cycle time: the global planning process and disposition cycle times.
October 01, 2004
Columns and Departments
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10
In general, people in other countries pay less for brand-name prescription drugs than people in the US. As a result, some Americans travel to Canada or Mexico to get their prescriptions, and an increasing number are using the Internet to buy drugs from other countries.
October 01, 2004
Manufacturing
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Identifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.
October 01, 2004
Manufacturing
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A handful of facilities making 200 million single-dose units per year could fast-track the immunization of the developing world.