September/October 2003 Volume 23, Number 5



Country Profile: Belgium - Sep/Oct 2003
This section takes a look at the pharmaceutical industry in Belgium; produced in collaboration with ISPE Belgium.
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Drug Product Bioequivalence During Development: Recommended Scientific and Communication Practices
by Charles F. Carney
This article describes the importance of maintaining bioequivalent performance for the various drug product lots produced during the development phase, and some procedural practices to manage the work and information in support of the product registration.
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Clinical Materials as Competitive Advantage
by Harry Clark
This article positions clinical materials management at the core of the evolving competitive arena in the pharmaceuticals industry and describes how CM organizations can be developed to confer strategic competitive advantage.
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Proactive Strategies for Matching Clinical Supply with Clinical Demand
by Massimo Eli, Jim Freeman, Rgen Midander, Rob Pizzie, Bob Shaffer
This article explores approaches to working in a high-risk R&D environment to manage the clinical supply chain.
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API Chemical Synthesis Trends in Reactor System Design
by Stephen Hall, Andy Stoker
This article discusses some of the more significant developments in API reactor design and use, and identifies some of the likely future trends. Future articles will focus on practical aspects of plant design, including heat transfer systems, material handling, ancillary equipment and safety.
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Poly(Ethylene Glycol)-Modified Gelatin Nanoparticles for Intracellular Delivery
by Goldie Kaul, Carolyn Lee-Parsons, Mansoor Amiji
This article examines the cytotoxicity, cellular uptake and trafficking, and expression efficiency of enhanced green-fluorescent protein (GFP) plasmid encapsulated in PEGylated gelatin nanoparticles.
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