Though there are many challenges in conducting international paediatric drug studies, the importance of ethical considerations in international clinical trials involving children cannot be overstated. Regulatory imperatives, economic incentives, new methods and technology and the chance to make a difference in the health of children worldwide provide compelling reasons to pursue global drug studies in children.

The biopharmaceutical contract manufacturing industry has long been established in North America and Western Europe, where contractors have been producing biologic clinical trial material and commercial products for biotechnology companies for more than a decade. As the industry matures, however, pricing pressures, primarily for large-scale production of biologics, are compelling some to consider outsourcing to contractors in lower-cost Asian regions.

Parallel Computing for Bioinformatics and Computational Biology
Author: Albert Y. Zomaya
Pharmaceutical Operations Management
Authors: Pankaj Mohan, Jarka Glassey, Gary A Montague
Clinical Trials - A practical guide to design, analysis, and reporting
Authors: Ameet Bakhai , Duolao Wang

Healthy margins and little appetite for risk have kept most pharmaceutical companies close to home, for all but their manufacturing activities. However, as financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was but also too attractive to ignore. This is especially true for conducting clinical trials, which can account for two-thirds of the cost of developing a new drug.

Treatment of patients with MDR-TB using the DOTS-Plus strategy and individualised drug regimens can be feasible, comparatively effective, and cost-effective in low and middle-income countries. The study was partly supported by grants provided to the World Health Organization by the United States Agency for International Development and the Bill and Melinda Gates Foundation, and a grant from the Special Programme for Training and Research in Tropical Diseases.

Dishman Pharma's manufacturing facility in Shanghai

Dishman Pharmaceuticals and Chemicals Ltd is setting up a new greenfield manufacturing facility in Shanghai Chemical Industry Park at a cost of US$10 million. The project is expected to go on stream by the end of 2007.

Novartis's new strategic biomedical R&D centre

Novartis announced plans to build an integrated biomedical Research & Development centre in Shanghai's Zhangjiang Hi-Tech Park. An investment of US$100 million has been planned to create Shanghai site, set to begin operations in May 2007.

First ever syringe leak testing machine by Bonfiglioli Pharma Machinery

The new leak tester to be launched by Bonfiglioli Pharma Machinery will be the first in the market and can be customised to the requirements of the client. The machine is fully computerised utilising a SCADA platform.

Millipore's innovative MobiusT Disposable TFF Assemblies

Millipore Corporation has announced the availability of new MobiusT disposable TFF assemblies, which offer flexible, self-contained solutions that reduce validation efforts, increase process speed and mitigate risks. The assemblies are optimized for compactness.