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A Rational Approach for Setting and Maintaining Specs for Biological and Biotech–Derived Products—Part 1
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| By
Izydor Apostol, PhD
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Timothy Schofield
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Gerhard Koeller, PhD
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Susan Powers, PhD
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Mary Stawicki
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Richard A. Wolfe, PhD
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A staged approach to limits should embrace future capabilities.
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Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit Operations
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| By
Anurag S. Rathore, PhD
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Ken Green
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Yas Hashimura
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Greg Nyberg
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Process-modeling tools can ensure smooth tech transfer.
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Avoiding the Pain of Out-of-Specification Results
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| By
Brian K. Nunnally, PhD
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Deedra F. Nunnally
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John S. McConnell
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Improving your quality operations by using sound statistical principles.
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Healthcare Reform Threatens Biotech Coverage and Access
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| By
Jill Wechsler
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The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.
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Biotech Survives Difficult Opening to 2008
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| By
G. Steven Burrill
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Following the market crisis of the first quarter of 2008, biotech IPOs and financing are down, but partnering continues, and mergers and acquisitions (M&As) remain hot.
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Funding the FDA, Finally
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Laura Bush
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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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Considerations When Outsourcing the Production of Clinical Material
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| By
Josée Ethier
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Chantal Déziel
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It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
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How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing
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| By
Andrew Sinclair
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The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.
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The Power of Hypothesis
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| By
Steven Walfish
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How to use hypothesis correctly, and understanding the difference between one-sample, two-sample, and z-test.
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Validation Failure is Not an Option. Should it be?
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| By
Stephan Krause, PhD
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The industry needs to open up to validation failures.
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