Drug Development

Articles

Editors' Picks of Pharmaceutical Science & Technology Innovations

In the Spotlight November 2007

Thin are the lines that separate stability, statistics, and chaos.

Agent in Place: Statistically Unstable

Elaine Martin is professor of industrial statistics in the School of Chemical Engineering and Advanced Materials at Newcastle University.

Gary Montague is professor of bioprocess control in the School of Chemical Engineering and Advanced Materials, Newcastle University.

The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.

The Challenge in Bioprocess Development: From Data to Knowledge

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.   This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

The Application of Quality by Design to Analytical Methods

Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.

Agent in Place: Vials and Villains

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

Simulated Moving Bed Chromatography: A Powerful Unit Operation

Poor processing and misguided projections lead to trashed product.

Self-destruction

The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.

GDP comes to the fore

The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.

Cultivating Compliance

Production sometimes follows the law of supply and reprimand.

Process and Scaling