The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
Sep 1, 2008
By:
Laura Bush
The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
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Aug 12, 2008
By:
Laura Bush
Since the principles of Quality by Design (QbD) for pharmaceutical manufacturing first emerged a few years ago, many companies have been struggling to understand the key concept of design space?what it is exactly, and how to establish it.
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Because less is known about drugs in early development, quality systems are even more important at this stage.
Aug 1, 2008
By:
Laura Bush
GMPs in Phase 1 is more important now than ever before.
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Just as antibody production is hitting maturity, areas like personalized medicine are presenting new difficulties.
Jul 1, 2008
By:
Laura Bush
Pushing frontiers in a maturing biotechnology industry.
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Jun 11, 2008
By:
Laura Bush
As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use?
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Increased agency funding, whether through budget allocations or user fees, will not prevent another heparin crisis.
Jun 1, 2008
By:
Laura Bush
A stronger FDA will benefit both the industry and the public. And it now looks like we are starting down a path to build up that strength.
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The FDA's current approach to process validation can be boiled down to one straightforward concept.
May 1, 2008
By:
Laura Bush
In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle.
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Now is a good time for companies to know their suppliers well.
Apr 1, 2008
By:
Laura Bush
Now is a good time for companies to know their suppliers well.
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Mar 12, 2008
By:
Laura Bush
When considering how follow-on biologics will be compared to innovator products, Emily Shacter has a favorite question
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