Pharmaceutical Technology
September 02, 2006
Special Section
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Mid-size companies are forcing through their market positions by developing their niche competencies and their flexibilities to be recognized as serious market contenders.
September 02, 2006
Special Section
30
9
The overall market size of the Southeast Asia region totals $7 billion, with a projected compound annual growth rate of about 13% through 2010.
September 02, 2006
Special Section
30
9
For once, casting originators against generic players might end up strengthening the industry across the board.
September 02, 2006
Articles
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9
As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.
September 02, 2006
Articles
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9
Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.
September 02, 2006
This Time Around
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9
I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.
September 02, 2006
Articles
30
9
The Product Quality Research Institute (PQRI) conducted an open, publicly available, electronic survey of current excipient-control strategies among pharmaceutical excipient manufacturers, excipient distributors, and drug-product manufacturers (excipient users). Among the major findings are:
September 02, 2006
In the Field
30
9
FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.
September 02, 2006
Articles
30
9
Potent-compound awareness training for operators is important to understand why the containment and controls are in place.
September 02, 2006
From The Editor
30
9
No matter how much we scamper about, the sheep just won't go where we want them to.
September 02, 2006
Agent-In-Place
30
9
Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.
September 02, 2006
Articles
30
9
The debate over functionality is not about to be settled anytime soon.
September 02, 2006
Packaging Forum
30
9
A hybrid system using paper and electronic pedigrees will be needed.
September 02, 2006
Washington Report
30
9
Partnerships launched 63 research projects that may translate into nine or 10 new drugs by 2010.
September 02, 2006
Viewpoint
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9
Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.