September/October 2003
Volume 23, Number 5

Theme: Clinical Materials

Table of Contents

Articles

Country Profile: Belgium
by ISPE Belgium Affiliate
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. Download Article...

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. Download Article...

Proactive Strategies for Matching Clinical Supply with Clinical Demand by Massimo Eli, Jim Freeman, Jörgen Midander, Rob Pizzie & Bob Shaffer This article explores approaches to working in a high-risk R&D environment to manage the clinical supply chain. Download Article...

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. Download Article...

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. Download Article...