Featured Articles
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FDA's New Guidance On Clinical Monitoring Arrives
By Jacquie Wiebe Mardell, Anhvita BioPharma Consulting
The FDA has released its long awaited update and replacement to the outdated 1988 guidance on clinical monitoring. The draft guidance for industry, Oversight of Clinical Investigations — A Risk Based Approach to Monitoring, is early evidence that the findings and recommendations of the Clinical Trials Transformation Initiative (CTTI), FDA's public-private partnership with Duke University among others, are beginning to take hold in practice in the clinical trials domain.
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Health Technology Assessment: What's The Value To Drug Discovery And Clinical Development?
By ICON
The most effective use of health technology assessment to maximize market access is to start early and update often. This article outlines the way in which economic thinking and the early application of health technology assessment can add value to all phases of drug discovery and clinical development.
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Spotlight On Separation And Filtration
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Datasheet: PTM/HT Membrane Filter Cartridges
Pharmaceutical-grade PTM/HT Membrane Filter Cartridges are high-temperature sterilizing-grade filter cartridges. Manufactured with inherently hydrophobic PTFE membrane, these cartridges are designed for use in the filtration of aggressive solvents and as compressed gas and vent filters.
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Datasheet: Pilot And Process Development Capabilities
Pall offers a range of tangential flow filtration systems, from small-scale
and process development to full-scale process systems. These
include standard systems, such as the Minimate, Centramate Pilot,
and Centrasette 5AT Systems, as well as standard and custom
engineered process systems.
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Technical Brief: Guidelines For Scale-Up With CUNO Zeta Plus Depth Filter Products
Process development engineers are responsible
for developing scale-up strategies for the efficient
and cost-effective manufacture of pharmaceutical, biological, and bioprocess-derived products at bench-scale, at pilot-plant scale, and at manufacturing scale.
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Brochure: Sartolab® P20 And Sartolab® P20 Plus
Pressure filtration units are practical holder for a lot of laboratory filtration applications. A surfactant-free cellulose acetate membrane with very low unspecific protein binding is welded into the polypropylene housing. Sartolab P20 Plus contains an additional 100% binder-free glass fiber prefilter on the cellulose acetate membrane.
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