Pharmaceutical Technology-04-02-2009

Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program.

Brief pharmaceutical news items for April 2009.

In a recent book, UK regulators explain how to establish a pharmacovigilance system.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

Obama's cost-containment and science-innovation initiatives need to overlap.

A review of recent product innovations, policy developments, and growth prospects in the excipients market.

President Obama's economic recovery plain includes goals such as reducing the number of uninsured citizens and improving the quality of healthcare.

A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group

The financial and economic downturn is likey to have long-term implications for outsourcing.

The role of automation suppliers is transforming to meet the pharma industry's demand for change.

GMP agents report on old products, aseptic violations, and unexpected emotions.

Despite the market downturn, private equity investors are lining up for pharmaceutical services.